Trial Title:
Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT ID:
NCT05721755
Condition:
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Oral Cavity Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage IV Hypopharyngeal Carcinoma AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Stage IV Lip and Oral Cavity Cancer AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Laryngeal Neoplasms
Mouth Neoplasms
Paclitaxel
Cisplatin
Carboplatin
Pembrolizumab
Fluorouracil
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Given IV
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
Arm group label:
Arm T (pembrolizumab, chemotherapy)
Other name:
Blastocarb
Other name:
Carboplat
Other name:
Carboplatin Hexal
Other name:
Carboplatino
Other name:
Carboplatinum
Other name:
Carbosin
Other name:
Carbosol
Other name:
Carbotec
Other name:
CBDCA
Other name:
Displata
Other name:
Ercar
Other name:
JM-8
Other name:
Nealorin
Other name:
Novoplatinum
Other name:
Paraplatin
Other name:
Paraplatin AQ
Other name:
Paraplatine
Other name:
Platinwas
Other name:
Ribocarbo
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Given IV
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
Arm group label:
Arm T (pembrolizumab, chemotherapy)
Other name:
Abiplatin
Other name:
Blastolem
Other name:
Briplatin
Other name:
CDDP
Other name:
Cis-diammine-dichloroplatinum
Other name:
Cis-diamminedichloridoplatinum
Other name:
Cis-diamminedichloro Platinum (II)
Other name:
Cis-diamminedichloroplatinum
Other name:
Cis-dichloroammine Platinum (II)
Other name:
Cis-platinous Diamine Dichloride
Other name:
Cis-platinum
Other name:
Cis-platinum II
Other name:
Cis-platinum II Diamine Dichloride
Other name:
Cismaplat
Other name:
Cisplatina
Other name:
Cisplatinum
Other name:
Cisplatyl
Other name:
Citoplatino
Other name:
Citosin
Other name:
Cysplatyna
Other name:
DDP
Other name:
Lederplatin
Other name:
Metaplatin
Other name:
Neoplatin
Other name:
Peyrone's Chloride
Other name:
Peyrone's Salt
Other name:
Placis
Other name:
Plastistil
Other name:
Platamine
Other name:
Platiblastin
Other name:
Platiblastin-S
Other name:
Platinex
Other name:
Platinol
Other name:
Platinol- AQ
Other name:
Platinol-AQ
Other name:
Platinol-AQ VHA Plus
Other name:
Platinoxan
Other name:
Platinum
Other name:
Platinum Diamminodichloride
Other name:
Platiran
Other name:
Platistin
Other name:
Platosin
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT and/or PET/CT
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
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:
Drug
Intervention name:
Fluorouracil
Description:
Given IV
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
Arm group label:
Arm T (pembrolizumab, chemotherapy)
Other name:
5 Fluorouracil
Other name:
5 Fluorouracilum
Other name:
5 FU
Other name:
5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Other name:
5-Fluorouracil
Other name:
5-Fluracil
Other name:
5-Fu
Other name:
5FU
Other name:
AccuSite
Other name:
Carac
Other name:
Fluoro Uracil
Other name:
Fluouracil
Other name:
Flurablastin
Other name:
Fluracedyl
Other name:
Fluracil
Other name:
Fluril
Other name:
Fluroblastin
Other name:
Ribofluor
Other name:
Ro 2-9757
Other name:
Ro-2-9757
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
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:
Drug
Intervention name:
Paclitaxel
Description:
Given IV
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
Arm group label:
Arm T (pembrolizumab, chemotherapy)
Other name:
Anzatax
Other name:
Asotax
Other name:
Bristaxol
Other name:
Praxel
Other name:
Taxol
Other name:
Taxol Konzentrat
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Given IV
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
Arm group label:
Arm T (pembrolizumab, chemotherapy)
Other name:
Keytruda
Other name:
Lambrolizumab
Other name:
MK-3475
Other name:
SCH 900475
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm A (pembrolizumab and radiation)
Arm group label:
Arm B (pembrolizumab monotherapy)
Other name:
Quality of Life Assessment
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Undergo radiation therapy
Arm group label:
Arm A (pembrolizumab and radiation)
Other name:
Cancer Radiotherapy
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Summary:
This phase III trial compares pembrolizumab with radiation therapy to pembrolizumab
without radiation therapy (standard therapy) given after pembrolizumab plus chemotherapy
for the treatment of patients with squamous cell carcinoma of the head and neck that has
spread from where it first started (primary site) to other places in the body
(metastatic). Pembrolizumab is a type of immunotherapy that stimulates the body's immune
system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on
the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to
find and kill cancer cells. Radiation therapy uses high-powered rays to kill cancer
cells. Giving radiation with pembrolizumab may be more effective at treating patients
with metastatic head and neck cancer than the standard therapy of giving pembrolizumab
alone.
Detailed description:
PRIMARY OBJECTIVE:
I. To compare overall survival (OS) between immunotherapy plus consolidative radiotherapy
(CoRT) and immunotherapy alone following non-progression with systemic
chemoimmunotherapy.
SECONDARY OBJECTIVES:
I. To compare progression-free survival (PFS) between the two arms. II. To compare
time-to-treatment failure (TTF) between the two arms. III. To determine the risk of
non-hematologic high-grade (3 or higher) toxicity with the addition of CoRT.
IV. To establish the prognostic value of quantitative positron emission tomography (PET)
biomarkers at baseline (standardized uptake value maximum [SUVmax], metabolic tumor
volume [MTV], total lesion glycolysis [TLG]) for overall survival in both arms.
V. To establish the predictive value of (a) structured qualitative read (Hopkins
Criteria) and (b) quantitative analysis for assessment of the post-radiotherapy or
chemotherapy restaging PET/computed tomography (CT) to evaluate its association with
overall survival in both arms.
HEALTH-RELATED QUALITY-OF-LIFE (HRQL) OBJECTIVES:
I. To compare the time-to-definitive-deterioration (TTDD) between the two arms. (PRIMARY)
II. To compare the mean early change in the Functional Assessment of Cancer Therapy -
Head & Neck (FACT-HN) trial outcome index (TOI) between the arms, defined as the
difference between the cycle 7 time point and randomization. (SECONDARY) III. To compare
the time-to-deterioration (TTD) between the arms (first deterioration). (SECONDARY) IV.
To compare the nadir of the Functional Assessment of Cancer Therapy-Immune Checkpoint
Modulator (FACT-ICM) score over the course of study participation between the arms.
(EXPLORATORY) V. To compare quality-adjusted survival between the arms. (EXPLORATORY)
EXPLORATORY OBJECTIVES:
I. To identify differences in patterns-of-failure with respect to local regional and
distant recurrences following CoRT versus immunotherapy alone.
II. To evaluate the risk of tracheostomy and/or gastrostomy in patients treated with CoRT
versus immunotherapy alone.
OUTLINE:
STEP 1: Patients who have not completed initial systemic therapy prior to enrollment are
assigned to Arm T and patients who have completed initial systemic therapy prior to
enrollment are assigned to Arm S.
ARM T: Patients receive pembrolizumab intravenously (IV) with carboplatin IV and
paclitaxel IV, or with cisplatin IV and fluorouracil IV, or with carboplatin IV and
fluorouracil IV on study.
ARM S: Patients proceed directly to Step II.
STEP II: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive one cycle of pembrolizumab IV with carboplatin IV and paclitaxel
IV, or with cisplatin IV and fluorouracil IV, or with carboplatin IV, and fluorouracil IV
on study and then receive pembrolizumab IV with radiation therapy on study. Patients also
undergo CT, PET/CT, and/or magnetic resonance imaging (MRI) throughout the trial.
ARM B: Patients receive one cycle of pembrolizumab IV with carboplatin IV and paclitaxel
IV, or with cisplatin IV and fluorouracil IV, or with carboplatin IV, and fluorouracil IV
on study and then receive pembrolizumab IV monotherapy on study. Patients also undergo
CT, PET/CT, and/or MRI throughout the trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- STEP 1 REGISTRATION:
- Patient must be >= 18 years of age
- Patient must have biopsy-proven metastatic squamous cell carcinoma, originating in
the oral cavity, larynx, oropharynx, or hypopharynx, with active disease present in
both the head and neck and distant sites
- NOTE: The tumor from an oropharynx primary site must have known p16 status; p16
positive cancer of unknown primary is allowed as well, provided the disease
presentation in consistent with a head and neck primary
- Patient can have prior surgical resection of a primary cancer in the head and neck
at any previous time, however, residual/recurrent disease in the head and neck must
be present on baseline imaging
- Any effects from prior cancer therapy for other diseases must be fully resolved and
not pose a problem for giving the treatment on this trial
- Patient must have 4 or fewer metastatic sites prior to starting any treatment, with
thoracic nodal disease considered a single site if encompassable in a tolerable
radiotherapy hypofractionated field (i.e.,15 fractions or less)
- NOTE: Contiguous/adjacent metastases treatable in a single stereotactic field
may be considered a single site
- NOTE: Patients with additional indeterminate findings such that the total
number of metastatic sites would be more than 4 may be enrolled if a
non-malignant etiology to these findings is a reasonable consideration
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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
- Patients must have measurable disease as follows:
- For patients who have not started any initial systemic therapy (with
pembrolizumab + chemotherapy) must have measurable disease documented by CT of
the neck and chest, and abdomen obtained within 28 days prior to Step 1
registration
- For patients who have started or completed their 3 cycles of initial systemic
therapy (with pembrolizumab + chemotherapy) must have measurable disease
documented by CT of the neck, chest and abdomen obtained within 28 days prior
to the start of their initial systemic therapy
- Leukocytes >= 3,000/mcL (obtained =< 28 days prior to Step 1 registration or prior
to the start of any chemotherapy if on Arm T)
- Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 28 days prior to Step 1
registration or prior to the start of any chemotherapy if on Arm T)
- Platelets >= 100,000/mcL (obtained =< 28 days prior to Step 1 registration or prior
to the start of any chemotherapy if on Arm T)
- Total bilirubin =< institutional upper limit of normal (ULN). Patients with a total
bilirubin > 1.5 x ULN, that is attributed to confirmed Gilbert's syndrome, are
allowed after consultation and approval from their treating physician (obtained =<
28 days prior to Step 1 registration or prior to the start of any chemotherapy if on
Arm T)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT])
=< 3.0 x institutional ULN (obtained =< 28 days prior to Step 1 registration or
prior to the start of any chemotherapy if on Arm T)
- Creatinine clearance: Glomerular filtration rate (GFR) >= 50 mL/min/1.73m^2 (for
patients receiving carboplatin-based regimens, GFR > 30 mL/min/1.73m^2) (obtained =<
28 days prior to Step 1 registration or prior to the start of any chemotherapy if on
Arm T)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of Step 1 registration are
eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated
- 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
- 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
- Patients on Arm S must have received chemoimmunotherapy
- Patients will be enrolled in the quality of life (QOL) study if the patient can read
and understand English, Spanish, French or Chinese (simplified or traditional
characters)
- NOTE: Sites cannot translate the associated QOL forms
- Patients of childbearing potential and/or sexually active patients must not expect
to conceive or father children by using an accepted and effective method(s) of
contraception or by abstaining from sexual intercourse for the duration of their
participation in the study. Patients of childbearing potential must continue
contraceptive measures for 4 months after the last dose of protocol treatment and
must not breastfeed while on study treatment through 4 months after the last dose of
protocol treatment
- STEP 2 RANDOMIZATION:
- Patient must have ECOG performance status 0-2
- Patient must have completed 3 cycles of initial systemic chemotherapy
- For patients registered to Arm S on Step 1, patients must have at least stable
disease after completing 3 cycles of pembrolizumab + chemotherapy
- Patient must have no signs of progression (complete response [CR]/partial response
[PR] or stable disease [SD]) on restaging imaging (consisting of neck, chest, and
abdomen CT). Restaging imaging must have been done after completion of initial
systemic chemotherapy with pembrolizumab + chemotherapy on Step 1 and within 7 days
prior to step 2 randomization. Patients with stable or responding radiologic
response are eligible for Step 2
Exclusion Criteria:
- Patients must not have prior head and neck radiotherapy
- Patient must not have an active autoimmune disease (i.e., inflammatory bowel
disease, systemic lupus erythematosus, rheumatoid arthritis, etc.) that has required
systemic treatment (i.e., disease modifying agents, corticosteroids, or
immunosuppressive drugs) in past 2 years. Replacement therapy (i.e., thyroxine,
insulin, physiologic corticosteroid replacement) is not considered a form of
systemic treatment and is allowed
- 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. All patients of childbearing potential must have a
blood test or urine study within 14 days prior to Step 1 registration 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: 1) has achieved menarche at some point, 2) has not undergone a
hysterectomy or bilateral oophorectomy; or 3) 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 not have received any live vaccine within 30 days prior to Step 1
registration and while participating in the study. Live vaccines include, but are
not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever,
rabies, bacillus Calmette Guerin (BCG), and typhoid (oral) vaccine. Patients are
permitted to receive inactivated vaccines and any non-live vaccines including those
for the seasonal influenza and coronavirus disease 2019 (COVID-19) (Note: intranasal
influenza vaccines, such as Flu-Mist trademark are live attenuated vaccines and are
not allowed). If possible, it is recommended to separate study drug administration
from vaccine administration by about a week (primarily, in order to minimize an
overlap of adverse events
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center-International Plaza
Address:
City:
Tampa
Zip:
33607
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-679-0775
Email:
ClinicalTrials@moffitt.org
Investigator:
Last name:
Jimmy J. Caudell
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center - McKinley Campus
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-679-0775
Email:
ClinicalTrials@moffitt.org
Investigator:
Last name:
Jimmy J. Caudell
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-679-0775
Email:
ClinicalTrials@moffitt.org
Investigator:
Last name:
Jimmy J. Caudell
Email:
Principal Investigator
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-946-7447
Investigator:
Last name:
Soumon Rudra
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Boise
Address:
City:
Boise
Zip:
83712
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Alison K. Conlin
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Fruitland
Address:
City:
Fruitland
Zip:
83619
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Alison K. Conlin
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Meridian
Address:
City:
Meridian
Zip:
83642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Alison K. Conlin
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Nampa
Address:
City:
Nampa
Zip:
83686
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Alison K. Conlin
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Cancer Institute - Twin Falls
Address:
City:
Twin Falls
Zip:
83301
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
208-381-2774
Email:
eslinget@slhs.org
Investigator:
Last name:
Alison K. Conlin
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:
Ameen Salahudeen
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:
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:
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:
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:
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:
Seema Harichand-Herdt
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:
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:
Sanford Joe Lueken Cancer Center
Address:
City:
Bemidji
Zip:
56601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-333-5000
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Freeman Health System
Address:
City:
Joplin
Zip:
64804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
417-347-4030
Email:
LJCrockett@freemanhealth.com
Investigator:
Last name:
Jay W. Carlson
Email:
Principal Investigator
Facility:
Name:
Sands Cancer Center
Address:
City:
Canandaigua
Zip:
14424
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
585-396-6161
Investigator:
Last name:
Yuhchyau Chen
Email:
Principal Investigator
Facility:
Name:
Wilmot Cancer Institute Radiation Oncology at Greece
Address:
City:
Rochester
Zip:
14606
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
585-758-7877
Investigator:
Last name:
Yuhchyau Chen
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:
Stony Brook University Medical Center
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-862-2215
Investigator:
Last name:
Mark Ashamalla
Email:
Principal Investigator
Facility:
Name:
Wilmot Cancer Institute at Webster
Address:
City:
Webster
Zip:
14580
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
WCICTOresearch@urmc.rochester.edu
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:
UH Seidman Cancer Center at UH Avon Health Center
Address:
City:
Avon
Zip:
44011
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Investigator:
Last name:
Jennifer A. Dorth
Email:
Principal Investigator
Facility:
Name:
Case Western Reserve University
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Jennifer A. Dorth
Email:
Principal Investigator
Facility:
Name:
UH Seidman Cancer Center at Lake Health Mentor Campus
Address:
City:
Mentor
Zip:
44060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Jennifer A. Dorth
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:
Christina Henson
Email:
Principal Investigator
Facility:
Name:
Providence Newberg Medical Center
Address:
City:
Newberg
Zip:
97132
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Alison K. Conlin
Email:
Principal Investigator
Facility:
Name:
Providence Saint Vincent Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Alison K. Conlin
Email:
Principal Investigator
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
215-728-4790
Investigator:
Last name:
Jessica R. Bauman
Email:
Principal Investigator
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
843-792-9321
Email:
hcc-clinical-trials@musc.edu
Investigator:
Last name:
Bhishamjit S. Chera
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:
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:
Erin R. Alesi
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:
Erin R. Alesi
Email:
Principal Investigator
Facility:
Name:
Langlade Hospital and Cancer Center
Address:
City:
Antigo
Zip:
54409
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-623-9869
Email:
Juli.Alford@aspirus.org
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Gundersen Lutheran Medical Center
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
608-775-2385
Email:
cancerctr@gundersenhealth.org
Investigator:
Last name:
Kurt Oettel
Email:
Principal Investigator
Facility:
Name:
ProHealth D N Greenwald Center
Address:
City:
Mukwonago
Zip:
53149
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
research.institute@phci.org
Investigator:
Last name:
Timothy R. Wassenaar
Email:
Principal Investigator
Facility:
Name:
ProHealth Oconomowoc Memorial Hospital
Address:
City:
Oconomowoc
Zip:
53066
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
262-928-7878
Investigator:
Last name:
Timothy R. Wassenaar
Email:
Principal Investigator
Facility:
Name:
Ascension Saint Mary's Hospital
Address:
City:
Rhinelander
Zip:
54501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-847-2353
Email:
Beth.Knetter@aspirus.org
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Ascension Saint Michael's Hospital
Address:
City:
Stevens Point
Zip:
54481
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-847-2353
Email:
Beth.Knetter@aspirus.org
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
UW Cancer Center at ProHealth Care
Address:
City:
Waukesha
Zip:
53188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
262-928-5539
Email:
Chanda.miller@phci.org
Investigator:
Last name:
Timothy R. Wassenaar
Email:
Principal Investigator
Facility:
Name:
Aspirus Regional Cancer Center
Address:
City:
Wausau
Zip:
54401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-405-6866
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Cancer Care - Wisconsin Rapids
Address:
City:
Wisconsin Rapids
Zip:
54494
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-422-7718
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Start date:
June 8, 2023
Completion date:
March 31, 2030
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/NCT05721755
