Trial Title:
Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
NCT ID:
NCT05863351
Condition:
Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Arm I (usual care)
Arm group label:
Arm II (SAbR, usual care)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm I (usual care)
Arm group label:
Arm II (SAbR, usual care)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (usual care)
Arm group label:
Arm II (SAbR, usual care)
Intervention type:
Procedure
Intervention name:
Stereotactic Ablative Radiotherapy
Description:
Undergo SAbR
Arm group label:
Arm II (SAbR, usual care)
Other name:
SABER
Other name:
SABR/SBRT
Intervention type:
Procedure
Intervention name:
Systemic Therapy
Description:
Given standard of care systemic therapy
Arm group label:
Arm I (usual care)
Arm group label:
Arm II (SAbR, usual care)
Summary:
This phase III trial compares the effect of stero-ablative radiotherapy (SAbR) followed
by standard of care systemic therapy, to standard of care systemic therapy alone, in
patients with kidney cancer that has spread from where it first started (primary site) to
a limited (2-5) number of places in the body (metastatic). Study doctors want to find out
if this approach is better or worse than the usual approach for metastatic kidney cancer.
The usual approach is defined as the care most people get for metastatic kidney cancer
which includes systemic therapy such as immunotherapy (given through the veins) and/or
small molecular inhibitor (tablets taken by mouth). Radiotherapy uses high energy x-rays
to kill cancer cells and shrink tumors. SAbR uses special equipment to position a patient
and deliver radiation to tumors with high precision. Giving SAbR prior to systemic
therapy may kill more tumor cells than the usual approach, which is systemic therapy
alone.
Detailed description:
PRIMARY OBJECTIVES:
I. To compare overall survival (OS) between patients receiving SAbR + systemic therapy
(SABR+ST) versus systemic therapy (ST) only.
II. To compare average adverse event (AE) score between SAbR+ST arm and ST only arm.
SECONDARY OBJECTIVES:
I. To compare global health status / quality of life (QOL) between patients receiving
SAbR+ST versus ST only.
II. To compare progression-free survival (PFS) between the arms.
EXPLORATORY OBJECTIVES:
I. To estimate PFS on first line systemic therapy (PFS-SST) in the SAbR+ST arm and
compare with first line systemic therapy PFS of the ST arm.
II. To explore local control from SAbR by looking at the amount of local failures after
SAbR in the SAbR+ST arm.
III. To assess the cost-effectiveness between the arms in terms of cost per unit gain in
quality-of-life years.
QOL OBJECTIVES:
I. To compare global health status / quality of life (QOL) between patients receiving
SabR+ST versus ST only using the National Comprehensive Cancer Network (NCCN) /
Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index -19 item (NFKSI-19).
II. To compare quality-adjusted survival between patients randomized to receive SabR+ST
vs ST alone using European Quality of Life (EUROQOL) 5-dimension, 5-level (EQ-5D-5L) at
3, 6, 9, 12, 18, and 24 months.
III. To compare global health status / QOL of the NFKSI-19 at all of the 3, 6, 9, 12, 18,
and 24 month time points between patients randomized to receive SabR+ST versus ST alone.
IV. To compare scale scores of the NFKSI-19 (disease-related symptoms - physical
disease-related symptoms - emotional, treatment side effects, and function & well-being)
at 3, 6, 9, 12, 18, 24 months between patients randomized to receive SabR+ST versus ST
alone.
V. To compare time to global quality of life deterioration between patients randomized to
receive SabR+ST versus ST alone using NFKSI-19.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care systemic therapy on study.
ARM II: Patients undergo repeated SAbR until progression and then receive standard of
care systemic therapy on study.
Patients in both arms undergo computed tomography (CT) or magnetic resonance imaging
(MRI) throughout the trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient must be >= 18 years of age
- Patient must have a pathologically (histologically or cytologically) proven
diagnosis of renal cell carcinoma (RCC) prior to randomization
- Patient may have any RCC histology except a histology that has a sarcomatoid
component
- Patient must have primary site addressed by local therapy. If the primary RCC is
intact, the patient must undergo local treatment to the primary before randomization
- Patient must have favorable or intermediate International Metastatic RCC Database
Consortium (IMDC) risk (0-2) at the time of randomization
- Patient must have a total of between 2 and 5 metastatic lesions, as defined by
Response Evaluation Criteria in Solid Tumors (RECIST) criteria with imaging obtained
within 45 days prior to randomization
- Patient must have a documentation from a radiation oncologist confirming that all
sites are amenable to SAbR
- Patient may have received prior therapy in the adjuvant setting as long as potential
trial participants have recovered from clinically significant adverse events of
their most recent therapy/intervention prior to enrollment
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better
- All patients of childbearing potential must have a blood test or urine study within
14 days prior to randomization to rule out pregnancy
- A patient of childbearing potential is defined as anyone, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the
following criteria:
- Has achieved menarche at some point
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has not been naturally postmenopausal (amenorrhea following cancer therapy
does not rule out childbearing potential) for at least 24 consecutive
months (i.e., has had menses at any time in the preceding 24 consecutive
months)
- Patient must have the ability to understand and the willingness to sign a written
informed consent document. Patients with impaired decision-making capacity (IDMC)
who have a legally authorized representative (LAR) or caregiver and/or family member
available will also be considered eligible
- Patient must have a Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Patients must have adequate organ and bone marrow function as per the recommended
guidelines and the respective Food and Drug Administration [FDA] package insert
required for the systemic therapy chosen by the treating oncologist. We recognize
that patients may have varying levels of renal and liver function that will impact
which systemic therapy is appropriate for the patient. We do not require all
patients to have specific baseline laboratory thresholds but do ask the treating
oncologist to attest that the patient has adequate organ and bone marrow function to
safely receive one of the first line systemic therapies listed in the protocol as a
standard of care treatment option
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of randomization are eligible
for this trial. Testing for HIV is not required for entry onto the study
- For patients with history of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated. If no previous
history, testing for HBV is not required for entry onto the study
- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load. If no previous history,
testing for HCV is not required for entry onto the study
- In order to participate in the QOL portion of the protocol, the patient must speak
one of the languages in which the NFKSI-19 and EQ-5D-5L is available
- NOTE: Sites cannot translate the associated QOL forms
Exclusion Criteria:
- Patient must not have brain metastases
- Patient must not have metastasis involving the following locations: ultra-central
(within 2cm of carina) lung, invading gastrointestinal tract (such as esophagus,
stomach, intestines, colon, rectum), skin, and scalp
- Patient must not have received any prior systemic therapy (except for adjuvant
setting) for metastatic RCC
- Active autoimmune disease requiring ongoing therapy including systemic treatment
with corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications daily. Inhaled steroids and adrenal replacement
steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of
active autoimmune disease
- History of severe allergic, anaphylactic or other hypersensitivity reactions to
chimeric or humanized antibodies
- Active tuberculosis (purified protein derivative [PPD] response without active TB is
allowed)
- Uncontrolled hypertension (systolic blood pressure [BP] > 190mmHg or diastolic BP >
110mmHg)
- Major surgery within 30 days prior to randomization
- Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer,
or bone fracture within 30 days prior to randomization
- Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-STEMI
[NSTEMI], cerebrovascular accident [CVA], etc.) events within 180 days prior to
randomization
- Moderate or severe hepatic impairment (child-Pugh B or C)
- Untreated pulmonary embolism (PE) or deep-vein thrombosis (DVT) is not allowed.
Treated PE or DVT is allowed > 30 days from diagnosis and when not resulting in
respiratory impairment
- Unstable cardiac arrhythmia within 180 days prior to randomization
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess,
bowel obstruction, or gastric outlet obstruction within 180 days prior to
randomization
- History of or active inflammatory bowel disease
- Malabsorption syndrome within 30 days prior to randomization
- Patient must not be pregnant or breast-feeding due to the potential harm to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used
- Patient must not expect to conceive or father children by using accepted and
effective method(s) of contraception or by abstaining from sexual intercourse for
the duration of their participation in the study and for 6 months after the last
dose of protocol treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham Cancer Center
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Mayo Clinic Hospital in Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-776-0015
Investigator:
Last name:
Anne W. Rajkumar
Email:
Principal Investigator
Facility:
Name:
UCHealth University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
720-848-0650
Investigator:
Last name:
Tyler Robin
Email:
Principal Investigator
Facility:
Name:
Poudre Valley Hospital
Address:
City:
Fort Collins
Zip:
80524
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
970-297-6150
Investigator:
Last name:
Tyler Robin
Email:
Principal Investigator
Facility:
Name:
Cancer Care and Hematology-Fort Collins
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
ecog.rss@jimmy.harvard.edu
Investigator:
Last name:
Tyler Robin
Email:
Principal Investigator
Facility:
Name:
UCHealth Greeley Hospital
Address:
City:
Greeley
Zip:
80631
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
ecog.rss@jimmy.harvard.edu
Investigator:
Last name:
Tyler Robin
Email:
Principal Investigator
Facility:
Name:
UCHealth Highlands Ranch Hospital
Address:
City:
Highlands Ranch
Zip:
80129
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
720-848-0650
Investigator:
Last name:
Tyler Robin
Email:
Principal Investigator
Facility:
Name:
Medical Center of the Rockies
Address:
City:
Loveland
Zip:
80538
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
970-203-7083
Investigator:
Last name:
Tyler Robin
Email:
Principal Investigator
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
202-243-2373
Email:
jquiver1@jhmi.edu
Investigator:
Last name:
Yasser Ged
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-776-0015
Investigator:
Last name:
Anne W. Rajkumar
Email:
Principal Investigator
Facility:
Name:
OSF Saint Joseph Medical Center
Address:
City:
Bloomington
Zip:
61701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Bloomington
Address:
City:
Bloomington
Zip:
61704
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Canton
Address:
City:
Canton
Zip:
61520
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Carthage
Address:
City:
Carthage
Zip:
62321
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Centralia Oncology Clinic
Address:
City:
Centralia
Zip:
62801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
Sean Sachdev
Email:
Principal Investigator
Facility:
Name:
University of Illinois
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-355-3046
Investigator:
Last name:
Matthew Koshy
Email:
Principal Investigator
Facility:
Name:
Carle at The Riverfront
Address:
City:
Danville
Zip:
61832
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@Carle.com
Investigator:
Last name:
Daniel H. Barnett
Email:
Principal Investigator
Facility:
Name:
Cancer Care Specialists of Illinois - Decatur
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Decatur Memorial Hospital
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Kishwaukee
Address:
City:
DeKalb
Zip:
60115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Sean Sachdev
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Effingham
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Daniel H. Barnett
Email:
Principal Investigator
Facility:
Name:
Crossroads Cancer Center
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Eureka
Address:
City:
Eureka
Zip:
61530
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Galesburg
Address:
City:
Galesburg
Zip:
61401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Delnor
Address:
City:
Geneva
Zip:
60134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Sean Sachdev
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Kewanee Clinic
Address:
City:
Kewanee
Zip:
61443
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Macomb
Address:
City:
Macomb
Zip:
61455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Mattoon/Charleston
Address:
City:
Mattoon
Zip:
61938
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Daniel H. Barnett
Email:
Principal Investigator
Facility:
Name:
Cancer Care Center of O'Fallon
Address:
City:
O'Fallon
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
HSHS Saint Elizabeth's Hospital
Address:
City:
O'Fallon
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Ottawa Clinic
Address:
City:
Ottawa
Zip:
61350
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Pekin
Address:
City:
Pekin
Zip:
61554
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Peoria
Address:
City:
Peoria
Zip:
61615
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Address:
City:
Peoria
Zip:
61615
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
OSF Saint Francis Medical Center
Address:
City:
Peoria
Zip:
61637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Peru
Address:
City:
Peru
Zip:
61354
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Princeton
Address:
City:
Princeton
Zip:
61356
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Southern Illinois University School of Medicine
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-545-7929
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Clinic
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-444-7541
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Memorial Medical Center
Address:
City:
Springfield
Zip:
62781
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-528-7541
Email:
pallante.beth@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Carle Cancer Center
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Daniel H. Barnett
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Warrenville
Address:
City:
Warrenville
Zip:
60555
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Sean Sachdev
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare - Washington
Address:
City:
Washington
Zip:
61571
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Mary Greeley Medical Center
Address:
City:
Ames
Zip:
50010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-956-4132
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
McFarland Clinic - Ames
Address:
City:
Ames
Zip:
50010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-239-4734
Email:
ksoder@mcfarlandclinic.com
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Ankeny
Address:
City:
Ankeny
Zip:
50023
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-282-2921
Investigator:
Last name:
Joshua Lukenbill
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital
Address:
City:
Cedar Rapids
Zip:
52403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
319-365-4673
Investigator:
Last name:
Deborah W. Wilbur
Email:
Principal Investigator
Facility:
Name:
Oncology Associates at Mercy Medical Center
Address:
City:
Cedar Rapids
Zip:
52403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
319-363-2690
Investigator:
Last name:
Deborah W. Wilbur
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - West Des Moines
Address:
City:
Clive
Zip:
50325
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Richard L. Deming
Email:
Principal Investigator
Facility:
Name:
Iowa Methodist Medical Center
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-6727
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Des Moines
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Laurel
Address:
City:
Des Moines
Zip:
50314
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Richard L. Deming
Email:
Principal Investigator
Facility:
Name:
University of Kansas Clinical Research Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
Olathe Health Cancer Center
Address:
City:
Olathe
Zip:
66061
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-355-3943
Email:
atheCCResearch@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center-Overland Park
Address:
City:
Overland Park
Zip:
66210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Indian Creek Campus
Address:
City:
Overland Park
Zip:
66211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
Salina Regional Health Center
Address:
City:
Salina
Zip:
67401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
785-452-7038
Email:
mleepers@srhc.com
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
University of Kansas Health System Saint Francis Campus
Address:
City:
Topeka
Zip:
66606
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
785-295-8000
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Westwood Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
The James Graham Brown Cancer Center at University of Louisville
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
502-562-3429
Investigator:
Last name:
Scott R. Silva
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University/Sidney Kimmel Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
410-955-8804
Email:
jhcccro@jhmi.edu
Investigator:
Last name:
Yasser Ged
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Address:
City:
Ann Arbor
Zip:
48106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Address:
City:
Brighton
Zip:
48114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health Medical Center - Brighton
Address:
City:
Brighton
Zip:
48114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Canton
Address:
City:
Canton
Zip:
48188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health Medical Center - Canton
Address:
City:
Canton
Zip:
48188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Chelsea Hospital
Address:
City:
Chelsea
Zip:
48118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Address:
City:
Chelsea
Zip:
48118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
University of Michigan Health - Sparrow Lansing
Address:
City:
Lansing
Zip:
48912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
517-364-3712
Email:
harsha.trivedi@umhsparrow.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Mary Mercy Livonia Hospital
Address:
City:
Livonia
Zip:
48154
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Address:
City:
Ypsilanti
Zip:
48197
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-776-0015
Investigator:
Last name:
Anne W. Rajkumar
Email:
Principal Investigator
Facility:
Name:
Saint Francis Medical Center
Address:
City:
Cape Girardeau
Zip:
63703
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
573-334-2230
Email:
sfmc@sfmc.net
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center - North
Address:
City:
Kansas City
Zip:
64154
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center - Lee's Summit
Address:
City:
Lee's Summit
Zip:
64064
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center at North Kansas City Hospital
Address:
City:
North Kansas City
Zip:
64116
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Elizabeth M. Wulff-Burchfield
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital South
Address:
City:
Saint Louis
Zip:
63128
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-525-6042
Email:
Danielle.Werle@mercy.net
Investigator:
Last name:
Jay W. Carlson
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital Saint Louis
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-251-7066
Investigator:
Last name:
Jay W. Carlson
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital Springfield
Address:
City:
Springfield
Zip:
65804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
417-269-4520
Investigator:
Last name:
Jay W. Carlson
Email:
Principal Investigator
Facility:
Name:
Bozeman Health Deaconess Hospital
Address:
City:
Bozeman
Zip:
59715
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-767-9355
Email:
askroswell@roswellpark.org
Investigator:
Last name:
Dheerendra Prasad
Email:
Principal Investigator
Facility:
Name:
Northwell Health/Center for Advanced Medicine
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
516-734-8896
Investigator:
Last name:
Louis Potters
Email:
Principal Investigator
Facility:
Name:
Lenox Hill Hospital
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
516-734-8896
Investigator:
Last name:
Louis Potters
Email:
Principal Investigator
Facility:
Name:
Manhattan Eye Ear and Throat Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-434-4460
Investigator:
Last name:
Louis Potters
Email:
Principal Investigator
Facility:
Name:
Highland Hospital
Address:
City:
Rochester
Zip:
14620
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
585-341-8113
Investigator:
Last name:
Yuhchyau Chen
Email:
Principal Investigator
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
585-275-5830
Investigator:
Last name:
Yuhchyau Chen
Email:
Principal Investigator
Facility:
Name:
Sanford Bismarck Medical Center
Address:
City:
Bismarck
Zip:
58501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
701-323-5760
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Sanford Broadway Medical Center
Address:
City:
Fargo
Zip:
58122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
701-323-5760
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Sanford Roger Maris Cancer Center
Address:
City:
Fargo
Zip:
58122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
701-234-6161
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Tyler Gunter
Email:
Principal Investigator
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Raquibul Hannan
Email:
raquibul.hannan@utsouthwestern.edu
Investigator:
Last name:
Raquibul Hannan
Email:
Principal Investigator
Facility:
Name:
Sanford Cancer Center Oncology Clinic
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
605-312-3320
Email:
OncologyClinicTrialsSF@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Sanford USD Medical Center - Sioux Falls
Address:
City:
Sioux Falls
Zip:
57117-5134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
605-312-3320
Email:
OncologyClinicalTrialsSF@SanfordHealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Simmons Cancer Center - RedBird
Address:
City:
Dallas
Zip:
75237
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@utsouthwestern.edu
Investigator:
Last name:
Qian Qin
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Qian Qin
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Fort Worth
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Qian Qin
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Clinical Center at Richardson/Plano
Address:
City:
Richardson
Zip:
75080
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
972-669-7044
Email:
Suzanne.cole@utsouthwestern.edu
Investigator:
Last name:
Qian Qin
Email:
Principal Investigator
Facility:
Name:
VCU Massey Cancer Center at Stony Point
Address:
City:
Richmond
Zip:
23235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
ctoclinops@vcu.edu
Investigator:
Last name:
John Melson
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University/Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
CTOclinops@vcu.edu
Investigator:
Last name:
John Melson
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-EC Cancer Center
Address:
City:
Eau Claire
Zip:
54701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Anderson A. Bauer
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center - University Hospital
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-622-8922
Email:
clinicaltrials@cancer.wisc.edu
Investigator:
Last name:
Christos Kyriakopoulos
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-Marshfield
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Status:
Suspended
Facility:
Name:
Marshfield Clinic-Minocqua Center
Address:
City:
Minocqua
Zip:
54548
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Anderson A. Bauer
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-Rice Lake
Address:
City:
Rice Lake
Zip:
54868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Anderson A. Bauer
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-River Region at Stevens Point
Address:
City:
Stevens Point
Zip:
54482
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Anderson A. Bauer
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center - Weston
Address:
City:
Weston
Zip:
54476
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Anderson A. Bauer
Email:
Principal Investigator
Start date:
September 7, 2023
Completion date:
August 1, 2037
Lead sponsor:
Agency:
ECOG-ACRIN Cancer Research Group
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Eastern Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05863351
