Active, not recruitingNCT03348631Updated Jun 15, 2026Results posted

Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer

A Phase 2 interventional study of Computed Tomography and Magnetic Resonance Imaging in Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Malignant Uterine Corpus Neoplasm and Recurrent Ovarian Carcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 582 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 62
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study summary

This phase II trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back (recurrent). Chemotherapy drugs, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess the clinical activity (overall response rate) of tazemetostat in patients with recurrent or persistent endometrioid or clear cell ovarian carcinoma, and patients with recurrent or persistent endometrioid endometrial adenocarcinoma.

II. To assess the clinical activity (response frequency) of tazemetostat in patients with recurrent or persistent clear cell ovarian carcinoma with an ARID1A mutation.

SECONDARY OBJECTIVES:

I. To examine the nature and degree of toxicity in patients with this regimen. II. To examine the progression free survival and overall survival for this patient population receiving tazemetostat.

III. To examine the 6 month clinical benefit rate in patients treated with this regimen. (20-OCT-2021) IV. To evaluate BAF250a expression in patient samples as an indicator of ARID1A mutation status and correlation with the clinical response to study drug. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021)

EXPLORATORY OBJECTIVES:

I. Whether or not the patient has an ARID1A mutation. (08/13/2019) Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) (Translational Research Integrated Objective) II. To examine the correlation between ARID1A mutation and BAF250a expression and to identify potential mutations predictive of response in patients with preserved BAF250a expression. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021)

OUTLINE:

Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) on study.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions studied

Recurrent Endometrial Endometrioid Adenocarcinoma
Recurrent Malignant Uterine Corpus Neoplasm
Recurrent Ovarian Carcinoma
Recurrent Ovarian Clear Cell Adenocarcinoma
Recurrent Ovarian Endometrioid Adenocarcinoma

Browse trials for

Ovarian Neoplasms 2,691

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Pathologically (histologically or cytologically) proven diagnosis of recurrent or persistent ovarian endometrioid or clear cell carcinoma, OR recurrent or persistent endometrioid endometrial adenocarcinoma; patients with recurrent endometrial cancer must have mismatch repair (MMR) immunohistochemistry completed; if they are found to be mismatch repair deficient, they should be offered treatment with immune checkpoint inhibition before consideration for treatment on trial; primary ovarian tumors must be at least 50% endometrioid or clear cell morphology, or have histologically documented recurrence with at least 50% endometrioid or clear cell morphology; institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian tumors (primary or recurrent lesions)
- Only patients with recurrent or persistent ovarian clear cell carcinoma (OCCC) with ARID1A pathologic variant or likely pathologic variant mutations per next generation sequencing (NGS) are eligible for entry (20-OCT-2021)
- Institutional pathology reports must be provided indicating at least 50% clear cell morphology for ovarian tumors (primary or recurrent lesions) and NGS report must be available for step 1 registration (20-OCT-2021) (09-DEC-2021)
- All other eligibility criteria and ineligibility criteria must be met for step 2 registration (20-OCT-2021) (09-DEC-2021)
All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
Patients must have had at least one, but no more than 3, prior cytotoxic regimens for management of primary disease; unlimited prior hormonal therapy, targeted therapy (including immunotherapy) or antiangiogenic therapy will be permitted
Patients must have completed prior therapy:
- Chemotherapy: cytotoxic
  - At least 28 days since last dose of chemotherapy prior to step 2 registration.
- Chemotherapy: nitrosoureas
  - At least 6 weeks since last dose of chemotherapy prior to step 2 registration.
- Chemotherapy: non-cytotoxic (e.g. small molecule inhibitor)
  - At least 28 days since last dose of chemotherapy prior to step 2 registration.
- Monoclonal antibody(ies)
  - At least 28 days since last dose of monoclonal antibody prior to step 2 registration.
- Immunotherapy
  - At least 28 days since last dose of immunotherapy prior to step 2 registration.
- Radiotherapy (RT)
  - At least 14 days from last local site RT prior to step 2 registration.
  - At least 21 days from stereotactic radiosurgery prior to step 2 registration.
  - At least 12 weeks from craniospinal, >= 50% radiation of pelvis or total body irradiation prior to step 2 registration.
  - Patients with central nervous system (CNS) disease should demonstrate evidence of stabilization after the 28-day time point after definitive treatment.
  - Full recovery of radiation related side effects prior to step 2 registration.
  - All subjects must have evidence of measurable disease outside of the radiation field at the time of step 2 registration
Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 14 days prior to step 2 registration
- Imaging of the chest, abdomen and pelvis within 28 days prior to step 2 registration
Age >= 18
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to step 2 registration
Platelets >= 100,000/mcl (within 14 days prior to step 2 registration)
Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to step 2 registration)
Hemoglobin >= 8 g/dL (within 14 days prior to step 2 registration)
Differential with no clinically significant morphologic abnormalities on complete blood count (CBC) testing; manual differential is encouraged, if clinically indicated, and in cases where an automated differential is abnormal (within 14 days prior to step 2 registration)
Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to step 2 registration)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (within 14 days prior to step 2 registration)
Total serum bilirubin level =\< 1.5 x ULN; direct bilirubin =\< ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's syndrome are eligible) (within 14 days prior to step 2 registration)
Patients must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of tazemetostat as judged by the treating physician (20-OCT-2021)
Women of childbearing potential must be willing and able to use adequate contraception (hormonal and barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; theoretically, CYP3A induction with tazemetostat use may result in the loss of efficacy in hormonal contraceptives, thus a barrier method of contraception must be used in addition to hormonal contraceptives due to the potential drug-drug interaction with tazemetostat (20-OCT-2021)
The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry
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 (08/13/2019)

Exclusion criteria

Exclusion Criteria:

Prior treatment with an investigational EZH2 inhibitor
A prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)
Abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing
A prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL)
Patients who have had therapeutic paracentesis or thoracentesis within 8 weeks prior to step 2 registration (20-OCT-2021)
Patients with clinical or radiographic evidence of bowel obstruction (20-OCT-2021)
Severe, active co-morbidity per the treating investigator's discretion
Pregnant or lactating patients
Known human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with tazemetostat; in addition, treatments involved in this protocol may be immunosuppressive, increasing the risk of lethal infections in this patient population
Treatment with strong and moderate inhibitors or inducers of CYP3A within 14 days of step 2 registration and during the study treatment (20-OCT-2021)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 62 participants (actual)

Study arms

Experimental
Treatment (tazemetostat)
Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Drug: Tazemetostat

Interventions

ProcedureComputed Tomography
Undergo CT scan
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
ProcedureMagnetic Resonance Imaging
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
DrugTazemetostat
Given PO
Also known as: E 7438, E-7438, E7438, EPZ 6438, EPZ-6438, EPZ6438

What researchers measure

Primary outcomes

Tumor Response
Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The statistic reported is the response rate (i.e. (total responses / total at risk) \* 100).
Time frame: Up to 6 months

Secondary outcomes

Tumor Response in Patients With ARID1A Mutations Using Tumor Response (Removed as of Version Date 20-OCT-2021)
Will be defined by RECIST v 1.1.
Time frame: Up to 6 months
6-month Progression Free Survival (Clinical Benefit Rate)
Six-month progression free survival (clinical benefit rate). The clinical benefit rate is the total number (or percentage) of patients who had a complete response, or a partial response or who had stable disease for six months or more.
Time frame: Up to 6 months
Number of Patients With a Grade 3 (or Higher) Adverse Events
Will be assessed according to grade of toxicity by organ or organ system. This will be reported by group (Endometrial or Ovarian). This study reported adverse events by CTCAE v5.0.
Time frame: Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months).
Progression-free Survival
Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.
Time frame: Progression-free survival times were collected for a maximum of 30.0 months (interquartile range: 1.8 months, 5.5 months).
Overall Survival
Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.
Time frame: Overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).

Other outcomes

ARID1A Mutational Status
Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).
Time frame: Up to 6 months
BAF250a Expression
Will be assessed by immunohistochemistry. Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).
Time frame: Up to 6 months

Results

Posted Mar 6, 2025

Participant flow

Participant flow — Overall Study
Milestone	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
Started	19	43
Completed	16	42
Not completed	3	1
Withdrew: Not eligible, no treatment	0	1
Withdrew: Not eligible, treated	2	0
Withdrew: Eligible, no treatment	1	0

Outcome measures

PrimaryTumor Response

Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The statistic reported is the response rate (i.e. (total responses / total at risk) \* 100).

Time frame:: Up to 6 months
Reported as:: Number · Response/Patient (Percentage)

Tumor Response
Response/Patient (Percentage)	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
Tumor Response	0 (0 to 15)	4.7 (0.6 to 15.8)

SecondaryTumor Response in Patients With ARID1A Mutations Using Tumor Response (Removed as of Version Date 20-OCT-2021)

Will be defined by RECIST v 1.1.

Time frame:: Up to 6 months

Results for this outcome have not been posted.

Secondary6-month Progression Free Survival (Clinical Benefit Rate)

Six-month progression free survival (clinical benefit rate). The clinical benefit rate is the total number (or percentage) of patients who had a complete response, or a partial response or who had stable disease for six months or more.

Time frame:: Up to 6 months
Reported as:: Number · Percentage with 6-month PFS

6-month Progression Free Survival (Clinical Benefit Rate)
Percentage with 6-month PFS	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
6-month Progression Free Survival (Clinical Benefit Rate)	25 (7.3 to 52.4)	19 (8.6 to 34.1)

SecondaryNumber of Patients With a Grade 3 (or Higher) Adverse Events

Will be assessed according to grade of toxicity by organ or organ system. This will be reported by group (Endometrial or Ovarian). This study reported adverse events by CTCAE v5.0.

Time frame:: Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months).
Reported as:: Count of participants · Participants

Number of Patients With a Grade 3 (or Higher) Adverse Events
Participants	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
Number of Patients With a Grade 3 (or Higher) Adverse Events	6	20

SecondaryProgression-free Survival

Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.

Time frame:: Progression-free survival times were collected for a maximum of 30.0 months (interquartile range: 1.8 months, 5.5 months).
Reported as:: Median · months

Progression-free Survival
months	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
Progression-free Survival	2.05 (1.84 to 5.49)	3.04 (2.04 to 4.37)

SecondaryOverall Survival

Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.

Time frame:: Overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).
Reported as:: Median · months

Overall Survival
months	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
Overall Survival	25.3 (3.8 to NA)	13.7 (8.0 to 22.4)

Other pre-specifiedARID1A Mutational Status

Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).

Time frame:: Up to 6 months

Results for this outcome have not been posted.

Other pre-specifiedBAF250a Expression

Will be assessed by immunohistochemistry. Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).

Time frame:: Up to 6 months

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	11/16 (68.8%)	3/16 (18.8%)	15/16 (93.8%)
Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients	28/42 (66.7%)	12/42 (28.6%)	40/42 (95.2%)

Most frequent serious events

Showing 10 of 30

Most frequent serious events
Event	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
NauseaGastrointestinal disorders	2/16	3/42
Abdominal painGastrointestinal disorders	1/16	2/42
Colonic obstructionGastrointestinal disorders	1/16	0/42
VomitingGastrointestinal disorders	1/16	0/42
Disease progressionGeneral disorders	1/16	2/42
FatigueGeneral disorders	1/16	0/42
ArthralgiaMusculoskeletal and connective tissue disorders	1/16	0/42
MyalgiaMusculoskeletal and connective tissue disorders	1/16	0/42
AtaxiaNervous system disorders	1/16	0/42
ParesthesiaNervous system disorders	1/16	0/42

Most frequent other events

Showing 10 of 133

Most frequent other events
Event	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients
NauseaGastrointestinal disorders	6/16	23/42
FatigueGeneral disorders	7/16	20/42
AnemiaBlood and lymphatic system disorders	7/16	16/42
DiarrheaGastrointestinal disorders	6/16	9/42
Abdominal painGastrointestinal disorders	5/16	9/42
VomitingGastrointestinal disorders	3/16	13/42
AnorexiaMetabolism and nutrition disorders	3/16	12/42
DyspneaRespiratory, thoracic and mediastinal disorders	1/16	11/42
DysgeusiaNervous system disorders	4/16	6/42
HeadacheNervous system disorders	4/16	4/42

Baseline characteristics

All enrolled patients

Age, Customized
Age, Customized(Participants)	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients	Total
20-29 years	0	1	1
30-39 years	0	1	1
40-49 years	0	6	6
50-59 years	5	16	21
60-69 years	11	16	27
70-79 years	1	3	4
>= 80 years	2	0	2

Sex: Female, Male
Sex: Female, Male(Participants)	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients	Total
Female	19	43	62
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients	Total
Hispanic or Latino	0	2	2
Not Hispanic or Latino	19	40	59
Unknown or Not Reported	0	1	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients	Total
American Indian or Alaska Native	0	0	0
Asian	0	2	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	2	5
White	16	37	53
More than one race	0	0	0
Unknown or Not Reported	0	2	2

Study locations

582 sites

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska 99508, United States
Katmai Oncology Group
Anchorage, Alaska 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska 99508, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona 85338, United States
Kingman Regional Medical Center
Kingman, Arizona 86401, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054, United States
Mayo Clinic in Arizona
Scottsdale, Arizona 85259, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420, United States
PCR Oncology
Arroyo Grande, California 93420, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505, United States
UC San Diego Moores Cancer Center
La Jolla, California 92093, United States
Providence Queen of The Valley
Napa, California 94558, United States
Saint Joseph Hospital - Orange
Orange, California 92868, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444, United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909, United States
Memorial Hospital North
Colorado Springs, Colorado 80920, United States
Saint Francis Cancer Center
Colorado Springs, Colorado 80923, United States
AdventHealth Porter
Denver, Colorado 80210, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado 81301, United States
Mercy Medical Center
Durango, Colorado 81301, United States
Poudre Valley Hospital
Fort Collins, Colorado 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado 80631, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado 80228, United States
AdventHealth Littleton
Littleton, Colorado 80122, United States
Longmont United Hospital
Longmont, Colorado 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501, United States
Medical Center of the Rockies
Loveland, Colorado 80538, United States
AdventHealth Parker
Parker, Colorado 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510, United States
Yale University
New Haven, Connecticut 06520, United States
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut 06477, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385, United States
Florida Cancer Specialists - Bradenton Cancer Center
Bradenton, Florida 34205, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida 34232, United States
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida 34239, United States
Sarasota Memorial Hospital
Sarasota, Florida 34239, United States
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida 34275, United States
Florida Cancer Specialists - Venice Island
Venice, Florida 34285, United States
Northside Hospital
Atlanta, Georgia 30342, United States
Augusta University Medical Center
Augusta, Georgia 30912, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia 30265, United States
Memorial Health University Medical Center
Savannah, Georgia 31404, United States
Summit Cancer Care-Memorial
Savannah, Georgia 31404, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813, United States
Queen's Medical Center
Honolulu, Hawaii 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii 96817, United States
Kuakini Medical Center
Honolulu, Hawaii 96817, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii 96766, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii 96701, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii 96701, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho 83617, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301, United States
OSF Saint Anthony's Health Center
Alton, Illinois 62002, United States
Rush-Copley Medical Center
Aurora, Illinois 60504, United States

Showing the first 100 of 582 sites.

References and documents

Study documents

Protocol and statistical analysis plan · Jan 11, 2023
Informed consent form · Jan 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Registry details

Key details

Study ID: NCT03348631
Lead sponsor: National Cancer Institute (NCI)
Collaborators: NRG Oncology
Responsible party: Sponsor
First posted: Nov 21, 2017
Start date: May 1, 2019
Primary completion: Jul 28, 2023
Completion: Feb 12, 2027 (estimated)
Results posted: Mar 6, 2025
Last update: Jun 15, 2026

Study contacts

Ramez N Eskander

principal investigator · NRG Oncology

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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