Trial Title:
Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial
NCT ID:
NCT05710328
Condition:
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Positive Breast Carcinoma
Invasive Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Deoxyglucose
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Receive standard of care chemotherapy
Arm group label:
Diagnostic (FDG-PET/CT scan)
Other name:
Chemo
Other name:
Chemotherapy (NOS)
Other name:
Chemotherapy, Cancer, General
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (FDG-PET/CT scan)
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:
Other
Intervention name:
Fludeoxyglucose F-18
Description:
Given IV
Arm group label:
Diagnostic (FDG-PET/CT scan)
Other name:
18FDG
Other name:
FDG
Other name:
Fludeoxyglucose (18F)
Other name:
fludeoxyglucose F 18
Other name:
Fludeoxyglucose F18
Other name:
Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
Other name:
Fluorodeoxyglucose F18
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (FDG-PET/CT scan)
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:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo standard of care surgery
Arm group label:
Diagnostic (FDG-PET/CT scan)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
Summary:
This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG)
positron emission tomography/computed tomography (PET/CT) works in predicting response to
standard of care chemotherapy prior to surgery in patients with HER2-positive stage
IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT
imaging and helps to identify areas of active cancer. PET and CT are imaging techniques
that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT
may help doctors better decide if a patient needs more or less treatment before surgery
in order to get the best response. This study evaluates whether FDG-PET/CT is useful in
predicting a patient's response to standard of care chemotherapy.
Detailed description:
PRIMARY OBJECTIVE:
I. To estimate the negative predictive value (NPV) of neoadjuvant interim (ni)FDG-PET/CT
for pathologic complete response (pCR), using delta maximum standardized uptake value
corrected for lean body mass day 15 (deltaSULmaxD15), completed through central review,
of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant
HER2-directed therapy.
SECONDARY OBJECTIVES:
I. To estimate the sensitivity, specificity, and positive predictive value (PPV) of
niFDG-PET/CT for pCR, using deltaSULmaxD15 of the primary breast cancer at a threshold of
40%, in patients treated with neoadjuvant HER2-directed therapy.
II. To evaluate the performance of niFDG-PET/CT, using deltaSULmaxD15 of the primary
breast cancer at a threshold of 40%, as a predictor of 3-year event-free survival (EFS)
from time of study registration.
EXPLORATORY OBJECTIVES:
I. To estimate the NPV of niFDG-PET/CT for pCR, using deltaSULmaxD15 of the primary
breast cancer at a grid of alternative thresholds ranging from 30% to 60%, in patients
treated with neoadjuvant HER2-directed therapy.
II. To compare deltaSULmaxD15 using automated image analysis of FDG-PET/CT by AutoPERCIST
(trademark) to standard PET analysis software.
OUTLINE:
Patients receive FDG intravenously (IV), undergo PET/CT, receive standard of care
chemotherapy, and undergo standard of care surgery on study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients (all genders) must be >= 18 years of age.
- 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 an Eastern Cooperative Oncology Group (ECOG) performance status of
0-2.
- Patient must have histologically confirmed HER2-positive primary invasive breast
carcinoma by American Society of Clinical Oncology (ASCO)/College of American
Pathologists (CAP) guidelines that has been determined by local testing.
- Patient must have known (either positive or negative) hormone receptor (estrogen
receptor [ER] or progesterone receptor [PR]) status by local testing, per ASCO/CAP
guidelines. Patients with either hormone receptor-positive or hormone receptor-
negative HER2-positive breast cancer are eligible.
- Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage
IIa-IIIc according to anatomic staging table at diagnosis and below criteria.
- Patients without nodal involvement (cN0) are eligible if T size > 2.0 cm (T2-4)
- Patients with nodal involvement (cN1-3) are eligible if T2-4
- Patients with clinical T4d are not eligible
- Patients with bilateral invasive breast cancers are eligible if both cancers are
HER2-positive and at least one meets all protocol eligibility criteria and neither
cancer renders the patient ineligible.
- Patients with multiple ipsilateral invasive tumors are eligible as long as all
tumors are HER2-positive and at least one tumor focus meets all eligibility
criteria. Multiple lesions that appear part of the same index tumor do not require
additional biopsy/HER2 testing.
- Patient must plan to start a standard neoadjuvant pertuzumab (or other biosimilars)
based regimen.
- 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
this imaging intervention are eligible for this trial.
- Patients with human immunodeficiency virus (HIV) on effective anti-retroviral
therapy with undetectable viral load within 6 months of registration are eligible
for this trial.
- Patient must be participating in the trial at an institution which has agreed to
perform the imaging research studies, completed the Eastern Cooperative Oncology
Group-American College of Radiology Imaging Network Cancer Center Group (ECOG-ACRIN)
defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT
scanner approval.
- For patients who completed the baseline (T0) FDG-PET/CT PRIOR to registration,
neoadjuvant pertuzumab-based regimen must start after study registration and
within 21 days after the T0 scan.
- Patients must not have used colony stimulating growth factors within 14
days prior to completing a T0 scan done prior to registration.
Exclusion Criteria:
- Patient must not have any prior treatment for the current breast cancer, including
surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
- 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
teratogenic effects of FDG in addition to the radiation exposure during PET/CT. All
patients of childbearing potential must have a blood test or urine study within 7
days prior to registration to rule out pregnancy.
- NOTE: A pregnancy test within 7 days prior to the T0 scan is also required but
will only need to be done if a) the T0 scan is completed after study
registration and b) if the pregnancy test done prior to registration is
completed outside of the 7-day window.
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 any contraindication to FDG-PET/CT imaging which includes
routine glucose values > 200 mg/dL and severe claustrophobia.
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:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
205-934-0220
Email:
tmyrick@uab.edu
Investigator:
Last name:
Erica M. Stringer-Reasor
Email:
Principal Investigator
Facility:
Name:
Cancer Center at Saint Joseph's
Address:
City:
Phoenix
Zip:
85004
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
720-874-1881
Email:
ResearchInstituteInquiries@CommonSpirit.org
Investigator:
Last name:
Shahzad Siddique
Email:
Principal Investigator
Facility:
Name:
Los Angeles General Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Email:
uscnorrisinfo@med.usc.edu
Investigator:
Last name:
Peter S. Conti
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Investigator:
Last name:
Peter S. Conti
Email:
Principal Investigator
Facility:
Name:
Saint John's Cancer Institute
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
310-582-7448
Investigator:
Last name:
Parvin F. Peddi
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:
Cesar A. Santa-Maria
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:
Ciara C. O'Sullivan
Email:
Principal Investigator
Facility:
Name:
Hawaii Cancer Care - Westridge
Address:
City:
'Aiea
Zip:
96701
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-539-2273
Email:
info@hawaiicancercare.com
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
Hawaii Cancer Care Inc - Waterfront Plaza
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-524-6115
Email:
i.webster@hawaiicancercare.com
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
Queen's Cancer Cenrer - POB I
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-532-0315
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
Queen's Medical Center
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-545-8548
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
University of Hawaii Cancer Center
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-586-2979
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
Queen's Cancer Center - Kuakini
Address:
City:
Honolulu
Zip:
96817
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-531-8521
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
Kapiolani Medical Center for Women and Children
Address:
City:
Honolulu
Zip:
96826
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-983-6090
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
Castle Medical Center
Address:
City:
Kailua
Zip:
96734
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-823-5923
Email:
ctsucontact@westat.com
Investigator:
Last name:
Jami A. Fukui
Email:
Principal Investigator
Facility:
Name:
Wilcox Memorial Hospital and Kauai Medical Clinic
Address:
City:
Lihue
Zip:
96766
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
808-535-7960
Investigator:
Last name:
Jami A. Fukui
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:
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:
Regina M. Stein
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:
Kendrith M. Rowland
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:
Regina M. Stein
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:
Kendrith M. Rowland
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:
Regina M. Stein
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Lake Forest Hospital
Address:
City:
Lake Forest
Zip:
60045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
cancertrials@northwestern.edu
Investigator:
Last name:
Regina M. Stein
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:
Kendrith M. Rowland
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:
Kendrith M. Rowland
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:
Regina M. Stein
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:
Brian Dong
Email:
Principal Investigator
Facility:
Name:
Louisiana State University Health Science Center
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
504-210-3539
Email:
emede1@lsuhsc.edu
Investigator:
Last name:
Michelle M. Loch
Email:
Principal Investigator
Facility:
Name:
University Medical Center New Orleans
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
504-210-3539
Email:
emede1@lsuhsc.edu
Investigator:
Last name:
Michelle M. Loch
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:
Cesar A. Santa-Maria
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-442-3324
Investigator:
Last name:
Heather Jacene
Email:
Principal Investigator
Facility:
Name:
Wayne State University/Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
313-576-9790
Email:
ctoadmin@karmanos.org
Investigator:
Last name:
Michael S. Simon
Email:
Principal Investigator
Facility:
Name:
Minnesota Oncology - Burnsville
Address:
City:
Burnsville
Zip:
55337
Country:
United States
Status:
Suspended
Facility:
Name:
Mercy Hospital
Address:
City:
Coon Rapids
Zip:
55433
Country:
United States
Status:
Suspended
Facility:
Name:
Minnesota Oncology Hematology PA-Maplewood
Address:
City:
Maplewood
Zip:
55109
Country:
United States
Status:
Suspended
Facility:
Name:
Abbott-Northwestern Hospital
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Status:
Suspended
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:
Ciara C. O'Sullivan
Email:
Principal Investigator
Facility:
Name:
Park Nicollet Clinic - Saint Louis Park
Address:
City:
Saint Louis Park
Zip:
55416
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
952-993-1517
Email:
mmcorc@healthpartners.com
Investigator:
Last name:
David M. King
Email:
Principal Investigator
Facility:
Name:
United Hospital
Address:
City:
Saint Paul
Zip:
55102
Country:
United States
Status:
Suspended
Facility:
Name:
Minnesota Oncology Hematology PA-Woodbury
Address:
City:
Woodbury
Zip:
55125
Country:
United States
Status:
Suspended
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Oxford
Address:
City:
Oxford
Zip:
38655
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Drew S. Dill
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Desoto
Address:
City:
Southhaven
Zip:
38671
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Drew S. Dill
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:
CoxHealth South Hospital
Address:
City:
Springfield
Zip:
65807
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:
Nebraska Medicine-Bellevue
Address:
City:
Bellevue
Zip:
68123
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-6941
Email:
unmcrsa@unmc.edu
Investigator:
Last name:
Jairam Krishnamurthy
Email:
Principal Investigator
Facility:
Name:
Nebraska Medicine-Village Pointe
Address:
City:
Omaha
Zip:
68118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-5600
Investigator:
Last name:
Jairam Krishnamurthy
Email:
Principal Investigator
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-6941
Email:
unmcrsa@unmc.edu
Investigator:
Last name:
Jairam Krishnamurthy
Email:
Principal Investigator
Facility:
Name:
Cooper Hospital University Medical Center
Address:
City:
Camden
Zip:
08103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
856-325-6757
Investigator:
Last name:
Ahmed K. Abou Hussein
Email:
Principal Investigator
Facility:
Name:
Morristown Medical Center
Address:
City:
Morristown
Zip:
07960
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
973-971-5900
Investigator:
Last name:
Shilpi Gupta
Email:
Principal Investigator
Facility:
Name:
Inspira Medical Center Mullica Hill
Address:
City:
Mullica Hill
Zip:
08062
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
856-508-3500
Email:
DeNigrisJ@ihn.org
Investigator:
Last name:
Erev E. Tubb
Email:
Principal Investigator
Facility:
Name:
Saint Joseph's Regional Medical Center
Address:
City:
Paterson
Zip:
07503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
973-754-2207
Email:
HallL@sjhmc.org
Investigator:
Last name:
Elias Obeid
Email:
Principal Investigator
Facility:
Name:
Inspira Medical Center Vineland
Address:
City:
Vineland
Zip:
08360
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
856-641-7933
Investigator:
Last name:
Mylene S. Go
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center at Cooper-Voorhees
Address:
City:
Voorhees
Zip:
08043
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
856-325-6757
Investigator:
Last name:
Ahmed K. Abou Hussein
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Einstein Campus
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Della F. Makower
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:
Ellis G. Levine
Email:
Principal Investigator
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-668-0683
Email:
cancerclinicaltrials@med.unc.edu
Investigator:
Last name:
Jorge D. Oldan
Email:
Principal Investigator
Facility:
Name:
Indu and Raj Soin Medical Center
Address:
City:
Beavercreek
Zip:
45431
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Howard M. Gross
Email:
Principal Investigator
Facility:
Name:
MetroHealth Medical Center
Address:
City:
Cleveland
Zip:
44109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
216-778-7559
Email:
ababal@metrohealth.org
Investigator:
Last name:
Tonjeh M. Bah
Email:
Principal Investigator
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-293-5066
Email:
Jamesline@osumc.edu
Investigator:
Last name:
Kai C. Johnson
Email:
Principal Investigator
Facility:
Name:
Kettering Medical Center
Address:
City:
Kettering
Zip:
45429
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Howard M. Gross
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:
Wajeeha Razaq
Email:
Principal Investigator
Facility:
Name:
Bryn Mawr Hospital
Address:
City:
Bryn Mawr
Zip:
19010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
484-476-2649
Email:
turzoe@mlhs.org
Investigator:
Last name:
Arezoo Ghaneie
Email:
Principal Investigator
Facility:
Name:
Geisinger Medical Center
Address:
City:
Danville
Zip:
17822
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
570-271-5251
Email:
HemonCCTrials@geisinger.edu
Investigator:
Last name:
Nadia N. Ramdin
Email:
Principal Investigator
Facility:
Name:
Riddle Memorial Hospital
Address:
City:
Media
Zip:
19063
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
484-476-2649
Email:
turzoe@mlhs.org
Investigator:
Last name:
Arezoo Ghaneie
Email:
Principal Investigator
Facility:
Name:
Bryn Mawr Health Center
Address:
City:
Newtown Square
Zip:
19073
Country:
United States
Status:
Suspended
Facility:
Name:
Paoli Memorial Hospital
Address:
City:
Paoli
Zip:
19301
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
484-476-2649
Email:
turzoe@mlhs.org
Investigator:
Last name:
Arezoo Ghaneie
Email:
Principal Investigator
Facility:
Name:
Guthrie Medical Group PC-Robert Packer Hospital
Address:
City:
Sayre
Zip:
18840
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-836-0388
Investigator:
Last name:
Joyson Poulose
Email:
Principal Investigator
Facility:
Name:
Community Medical Center
Address:
City:
Scranton
Zip:
18510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
570-703-4768
Email:
HemonCCTrials@geisinger.edu
Investigator:
Last name:
Nadia N. Ramdin
Email:
Principal Investigator
Facility:
Name:
Chester County Hospital
Address:
City:
West Chester
Zip:
19380
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
610-431-5044
Email:
carolann.hoppes@pennmedicine.upenn.edu
Investigator:
Last name:
Maureen R. Hewitt
Email:
Principal Investigator
Facility:
Name:
Geisinger Wyoming Valley/Henry Cancer Center
Address:
City:
Wilkes-Barre
Zip:
18711
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
570-271-5251
Email:
HemonCCTrials@geisinger.edu
Investigator:
Last name:
Nadia N. Ramdin
Email:
Principal Investigator
Facility:
Name:
Lankenau Medical Center
Address:
City:
Wynnewood
Zip:
19096
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
484-476-2649
Email:
turzoe@mlhs.org
Investigator:
Last name:
Arezoo Ghaneie
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Collierville
Address:
City:
Collierville
Zip:
38017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Drew S. Dill
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Memphis
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Drew S. Dill
Email:
Principal Investigator
Facility:
Name:
Dell Seton Medical Center at The University of Texas
Address:
City:
Austin
Zip:
78701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
512-324-7991
Investigator:
Last name:
Om N. Pandey
Email:
Principal Investigator
Facility:
Name:
University of Texas at Austin
Address:
City:
Austin
Zip:
78712
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
512-232-1543
Email:
irb@austin.utexas.edu
Investigator:
Last name:
Om N. Pandey
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-424-2100
Email:
cancerinfo@hci.utah.edu
Investigator:
Last name:
Matthew Covington
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:
Masey M. Ross
Email:
Principal Investigator
Facility:
Name:
FHCC South Lake Union
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-804-8824
Investigator:
Last name:
Jennifer M. Specht
Email:
Principal Investigator
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-804-8824
Investigator:
Last name:
Jennifer M. Specht
Email:
Principal Investigator
Facility:
Name:
University of Washington Medical Center - Montlake
Address:
City:
Seattle
Zip:
98195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-804-8824
Investigator:
Last name:
Jennifer M. Specht
Email:
Principal Investigator
Facility:
Name:
Aurora Cancer Care-Southern Lakes VLCC
Address:
City:
Burlington
Zip:
53105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-302-2304
Email:
ncorp@aurora.org
Investigator:
Last name:
Thomas J. Saphner
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:
Dean A. Delmastro
Email:
Principal Investigator
Facility:
Name:
Aurora Health Care Germantown Health Center
Address:
City:
Germantown
Zip:
53022
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-302-2304
Email:
ncorp@aurora.org
Investigator:
Last name:
Thomas J. Saphner
Email:
Principal Investigator
Facility:
Name:
Saint Vincent Hospital Cancer Center Green Bay
Address:
City:
Green Bay
Zip:
54301
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
920-433-8889
Email:
ewd_research_admin@hshs.org
Investigator:
Last name:
Brian L. Burnette
Email:
Principal Investigator
Facility:
Name:
Saint Vincent Hospital Cancer Center at Saint Mary's
Address:
City:
Green Bay
Zip:
54303
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
920-433-8889
Email:
ewd_research_admin@hshs.org
Investigator:
Last name:
Brian L. Burnette
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center - Ladysmith
Address:
City:
Ladysmith
Zip:
54848
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Dean A. Delmastro
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:
Amy M. Fowler
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-Marshfield
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Status:
Suspended
Facility:
Name:
Aurora Saint Luke's Medical Center
Address:
City:
Milwaukee
Zip:
53215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-302-2304
Email:
ncorp@aurora.org
Investigator:
Last name:
Thomas J. Saphner
Email:
Principal Investigator
Facility:
Name:
Aurora Sinai Medical Center
Address:
City:
Milwaukee
Zip:
53233
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-302-2304
Email:
ncorp@aurora.org
Investigator:
Last name:
Thomas J. Saphner
Email:
Principal Investigator
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:
Dean A. Delmastro
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center - Neillsville
Address:
City:
Neillsville
Zip:
54456
Country:
United States
Status:
Suspended
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:
Dean A. Delmastro
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:
Dean A. Delmastro
Email:
Principal Investigator
Facility:
Name:
Aurora West Allis Medical Center
Address:
City:
West Allis
Zip:
53227
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-302-2304
Email:
ncorp@aurora.org
Investigator:
Last name:
Thomas J. Saphner
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:
Dean A. Delmastro
Email:
Principal Investigator
Facility:
Name:
Marshfield Clinic - Wisconsin Rapids Center
Address:
City:
Wisconsin Rapids
Zip:
54494
Country:
United States
Status:
Suspended
Facility:
Name:
Cancer Center-Metro Medical Center Bayamon
Address:
City:
Bayamon
Zip:
00959-5060
Country:
Puerto Rico
Status:
Suspended
Facility:
Name:
Doctors Cancer Center
Address:
City:
Manati
Zip:
00674
Country:
Puerto Rico
Status:
Suspended
Facility:
Name:
San Juan Community Oncology Group
Address:
City:
San Juan
Zip:
00917
Country:
Puerto Rico
Status:
Suspended
Facility:
Name:
Centro Comprensivo de Cancer de UPR
Address:
City:
San Juan
Zip:
00927
Country:
Puerto Rico
Status:
Suspended
Facility:
Name:
San Juan City Hospital
Address:
City:
San Juan
Zip:
00936
Country:
Puerto Rico
Status:
Suspended
Start date:
May 10, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
ECOG-ACRIN Cancer Research Group
Agency class:
Other
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/NCT05710328
