Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
Study Details
Study Description
Brief Summary
This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone [R-miniCHOP]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells. R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs, cyclophosphamide, doxorubicin, and vincristine. These 3 chemotherapy drugs, as well as oral azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patient's survival when compared to R-miniCHOP alone.
Detailed Description
PRIMARY OBJECTIVES:
- To determine if the addition of CC-486 (oral azacitidine) to R-miniCHOP results in excess toxicity compared to R-miniCHOP alone that would preclude the combination from being studied further. (Safety run-in) II. To determine if the CC-486 + R-miniCHOP regimen should be tested further (Phase III) against the control R-miniCHOP alone based on progression-free survival (PFS). (Phase II component) III. To compare the overall survival (OS) between CC-486 + R-miniCHOP and R-miniCHOP alone. (Phase III component)
SECONDARY OBJECTIVES:
-
To assess the feasibility of delivering at least 4 cycles of CC-486 with R-miniCHOP in this population.
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To assess toxicity for CC-486 + R-miniCHOP and for R-miniCHOP. III. To compare complete response rates, as defined by Lugano 2014 classification, between CC-486 + R-miniCHOP and R-miniCHOP alone.
INTEGRATED CORRELATIVE GERIATRIC ASSESSMENTS:
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To compare functioning as assessed by the S1918 Comprehensive Geriatric Assessment (S1918 CGA) between participants treated with CC-486 + R-miniCHOP versus R-miniCHOP alone.
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To evaluate if frailty status (fit/unfit versus [vs] frail/superfrail) as assessed by the FIL tool is associated with OS.
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To evaluate if frailty as measured by the FIL tool correlates with the summary frailty index as measured using components of the S1918 CGA.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
Beginning 7 days prior to starting [protocol treatment, all patients receive vincristine sulfate intravenously (IV) on day 1, and prednisone orally (PO) daily on days 1-7.
Patients are then randomized to 1 of 2 arms.
ARM I: Patients receive CC-486 PO for 7 days prior to cycle 1. Patients then receive CC-486 PO on days 8-21. Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV (or subcutaneously [SC] for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for cycles 1-6 (6 cycles total) in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically until 5 years from the date of registration.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (oral azacitidine, R-miniCHOP) Patients receive CC-486 PO for 7 days prior to cycle 1. Patients then receive CC-486 PO on days 8-21. Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for cycles 1-6 (6 cycles total) in the absence of disease progression or unacceptable toxicity. |
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Drug: Oral Azacitidine
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
Other: Questionnaire Administration
Ancillary studies
Biological: Rituximab
Given IV or SC
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
| Active Comparator: Arm II (R-miniCHOP) Patients receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Drug: Prednisone
Given PO
Other Names:
Other: Questionnaire Administration
Ancillary studies
Biological: Rituximab
Given IV or SC
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Excess toxicity as a result of adding oral azacitidine (CC-486) to reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-miniCHOP) (Safety run-in) [Up to completion of cycle 6]
Will determine if the addition of CC-486 to R-miniCHOP results in excess toxicity compared to R-miniCHOP alone that would preclude the combination from being studied further.
- Progression-free survival (PFS) (Phase II) [From date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 1 year]
Will determine if the CC-486 + R-miniCHOP regimen should be tested further (Phase III) against the control R-miniCHOP alone based on PFS. After accruing 130 patients (65 per arm, 21 months of accrual and potentially pausing accrual for 6 months follow-up to reach a target 63 events across arms), a one-sided stratified .10 log-rank test will inform a go/no-go decision based on sufficient evidence of efficacy to continue to the Phase III portion of the study.
- Overall survival (Phase III) [From date of registration to date of death due to any cause, assessed up to 2 years]
Will compare overall survival in the control arm of R-miniCHOP to the experimental arm of CC-486 (oral azacitidine) + R-miniCHOP. Will be evaluated using a 1-sided .025 level stratified logrank test.
Secondary Outcome Measures
- Metabolic complete response (CR) [Up to end of cycle 6 or end of treatment]
Will be defined using 2014 Lugano classification. Fisher's exact test will be used to compare CR rates between the experimental arm of CC-486 + R-miniCHOP and the control arm of R-miniCHOP alone.
- Incidence of adverse events [Until disease progression, assessed up to 5 years]
Will be assessed using Common Terminology Criteria for Adverse Events version 5. The maximum Grade for each toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Treatment-related toxicities between arms will be compared using Fisher's exact test.
- Overall survival (Phase III) [From date of registration to date of death due to any cause, assessed up to 5 years]
An additional secondary analysis of overall survival of the Phase III comparison will adjust for patients with identified double-hit phenotype in addition to the pre-specified stratification factors. Will also prospectively collect the number of days between diagnostic biopsy and cycle 1 day 1 of therapy for a pre-planned secondary analysis.
Other Outcome Measures
- Changes in function (Integrated Correlative Geriatric Assessments Substudy) [From time of randomization up to 24 months after date of registration]
Will be assessed by a Comprehensive Geriatric Assessment (Carolina Frailty Index [CFI] Score) between patients treated with CC-486 + R-miniCHOP and those treated with R-miniCHOP alone. Linear regression will be used for each examination, adjusting for the stratification factors from the clinical study and the baseline score (for the examination of change from 12 to 24 months, the 12-month score will be considered the baseline score). Although the number of timepoints is limited to 3, longitudinal assessments of the CFI Score over time will also be conducted using linear mixed models, adjusting for the stratification factors and the baseline score, with patient considered a random effect.
- Frailty status (fit/unfit vs frail) (Integrated Correlative Geriatric Assessments Substudy) [Baseline]
Will evaluate if frailty status (fit/unfit versus frail) as assessed by the Italian Lymphoma Foundation (FIL) tool is associated with overall survival. Multivariable Cox regression will be conducted, adjusting for the stratification variables and the randomized treatment arm as covariates. Will also examine whether randomization to CC-486 + R-miniCHOP is associated with better overall survival compared to treatment with R-miniCHOP alone in the subset of fit and unfit patients. Multivariable Cox regression will be conducted, adjusting for the stratification variables as covariates.
- Frailty status (Integrated Correlative Geriatric Assessments Substudy) [Up to 24 months after date of registration]
Will evaluate if frailty status (fit/unfit versus frail) as assessed by the FIL tool correlates with the summary frailty indexed as measured by the S1918 Comprehensive Geriatric Assessment (CGA). In particular, agreement between the FIL and CGA will measured using an unweighted Kappa statistic; moderate or better agreement is defined as a Kappa coefficient of >= 0.41.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants must have histologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL), Ann Arbor Stage IIX (bulky), III or IV. Participants with DLBCL transformed from follicular lymphoma (FL) or marginal zone lymphoma (MZL, including mucosa-associated lymphoid tissue [MALT] lymphomas), lymphoplasmacytic lymphoma (LPL), or nodular lymphocyte-predominant Hodgkin Lymphoma (NLPHL) are eligible. Participants with Grade IIIB follicular lymphoma (FL) or high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements are also eligible. Participants with DLBCL that arose from prior CLL (Richter's transformation) are not eligible.
-
As defined by the World Health Organization (WHO), eligible lymphoma subtypes include the following:
-
DLBCL, not otherwise specified (NOS)
-
DLBCL, germinal-center B-cell type (GCB)
-
DLBCL, activated B-cell type (ABC)
-
T-cell histiocyte-rich B-cell lymphomas (THRBCL)
-
Primary cutaneous DLBCL, leg type
-
Intravascular large B cell lymphoma
-
EBV+ DLBCL, NOS
-
DLBCL associated with chronic inflammation
-
HHV8+ DLBCL, NOS
-
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
-
High grade B-cell lymphoma, NOS
-
Follicular lymphoma grade 3b
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Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter >= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 42 days prior to registration.
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Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 26 weeks prior to registration). Participants with known HIV must have a CD4 count checked within 28 days prior to registration, but may proceed with therapy regardless of CD4 count.
-
All participants must be screened for chronic hepatitis B virus (HBV) within 28 days prior to registration. Participants with known HBV infection (positive serology) must also have a HBV viral load performed within 28 days prior to registration, and participants must have an undetectable HBV viral load on suppressive therapy within 28 days prior to registration. Participants found to be HBV carriers during screening are eligible and must receive standard of care prophylaxis. Participants with active hepatitis B (HBV viral load > 500 IU/mL) within 28 days prior to registration are not eligible
-
Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load within in 28 days prior to registration
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Participants must have a Zubrod performance status of 0-2
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Participants must have adequate renal function, as demonstrated by a creatinine clearance, calculated by the Cockcroft and Gault formula, of >= 30 ml/min that was obtained within 28 days prior to registration
-
Aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =< 2.5 x IULN (within 28 days prior to registration)
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Total bilirubin =< 2 x institutional upper limit of normal (IULN), unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver (within 28 days prior to registration). Note: If total bilirubin is elevated, and direct bilirubin is subsequently performed (within 28 days prior to registration) and resulted to be =< 2 x IULN, the participant will be considered eligible
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Absolute neutrophil count (ANC) >= 1000/mcL (within 28 days prior to registration)
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Platelets >= 75,000/mcL (within 28 days prior to registration)
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Hemoglobin (Hgb) >= 8 g/ dL (within 28 days prior to registration)
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If there is a documented lymphomatous involvement of the bone marrow, bone marrow function within 28 days prior to registration, as evidenced by:
-
ANC >= 500/mcL
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Platelets >= 50,000/mcL
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Hemoglobin (Hgb) >= 8 g/ dL
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Participants must have a left ventricular ejection (LVEF) fraction >= 45% as measured by echocardiogram or radionuclide (multigated acquisition scan [MUGA]) ventriculography within 56 days prior to registration
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For the duration of the study treatment period and for at least 4 months following the last dose of study drug, male participants must agree to use effective contraceptive methods during sexual contact with a female of childbearing potential (FCBP) and must agree to refrain from semen or sperm donation during the same timeframe. Effective contraceptive methods include a history of vasectomy, use of hormonal contraception or an intrauterine device (IUD) by the female partner, or use of condoms
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A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Exclusion Criteria:
-
Participants must not have known lymphomatous involvement of the central nervous system (CNS)
-
Participants must not have active inflammatory bowel disease (such as, Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism, or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
-
Participants must not have received any prior cytotoxic chemotherapy or rituximab for treatment of the newly diagnosed DLBCL except for the pre-phase treatment (within specified dose range) that may have either started before or may start after registration to S1918. Inhaled, nasal, and topical steroid use is allowed. Prior cytotoxic chemotherapy and/or antibody therapy for an indolent lymphoma prior to transformation is allowed. Up to 4 doses of intrathecal (IT) chemotherapy administered for central nervous system (CNS) prophylaxis is allowed in addition to protocol therapy. High-dose intravenous methotrexate is not allowed.
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Participants must not have received more than a cumulative of dose 250 mg/m^2 of prior doxorubicin (or equivalent dose of another anthracycline, such as epirubicin) therapy (at any time prior to registration).
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Participants must not currently be receiving any other investigational agents
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Participant must not have a history of allergic reactions attributed to azacitidine, mannitol, or other hypomethylating agents
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Participants must not have active infection (systemic fungal, bacterial, or viral infection) that is not controlled (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
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Participants must not have active cardiac disease within 26 weeks prior to registration, including: symptomatic congestive heart failure (New York Heart Association [NYHA] class 4), unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or myocardial infarction
-
Participants must not have >= grade 2 neuropathy, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to registration
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Participants must not have any other known uncontrolled intercurrent illness including, but not limited to ongoing psychiatric illness/social situations that would limit compliance with study requirements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner University Medical Center - Tucson | Tucson | Arizona | United States | 85719 |
| 2 | University of Arizona Cancer Center-North Campus | Tucson | Arizona | United States | 85719 |
| 3 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 4 | Kaiser Permanente-Anaheim | Anaheim | California | United States | 92806 |
| 5 | Kaiser Permanente-Baldwin Park | Baldwin Park | California | United States | 91706 |
| 6 | Kaiser Permanente-Bellflower | Bellflower | California | United States | 90706 |
| 7 | Tower Cancer Research Foundation | Beverly Hills | California | United States | 90211 |
| 8 | UC Irvine Health Cancer Center-Newport | Costa Mesa | California | United States | 92627 |
| 9 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 10 | Kaiser Permanente-Fontana | Fontana | California | United States | 92335 |
| 11 | Kaiser Permanente - Harbor City | Harbor City | California | United States | 90710 |
| 12 | City of Hope at Irvine Lennar | Irvine | California | United States | 92618 |
| 13 | Kaiser Permanente-Irvine | Irvine | California | United States | 92618 |
| 14 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 15 | Kaiser Permanente West Los Angeles | Los Angeles | California | United States | 90034 |
| 16 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 17 | Kaiser Permanente-Ontario | Ontario | California | United States | 91761 |
| 18 | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 19 | Stanford Cancer Institute Palo Alto | Palo Alto | California | United States | 94304 |
| 20 | Kaiser Permanente - Panorama City | Panorama City | California | United States | 91402 |
| 21 | Kaiser Permanente-Riverside | Riverside | California | United States | 92505 |
| 22 | Kaiser Permanente-San Diego Zion | San Diego | California | United States | 92120 |
| 23 | Kaiser Permanente-San Marcos | San Marcos | California | United States | 92078 |
| 24 | UCSF Cancer Center - San Mateo | San Mateo | California | United States | 94402 |
| 25 | Kaiser Permanente-Woodland Hills | Woodland Hills | California | United States | 91367 |
| 26 | Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | United States | 19713 |
| 27 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 28 | Medical Oncology Hematology Consultants PA | Newark | Delaware | United States | 19713 |
| 29 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 30 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 31 | Emory Saint Joseph's Hospital | Atlanta | Georgia | United States | 30342 |
| 32 | Augusta University Medical Center | Augusta | Georgia | United States | 30912 |
| 33 | Hawaii Cancer Care - Savio | 'Aiea | Hawaii | United States | 96701 |
| 34 | Pali Momi Medical Center | 'Aiea | Hawaii | United States | 96701 |
| 35 | Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | United States | 96813 |
| 36 | Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | United States | 96813 |
| 37 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 38 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813 |
| 39 | Queen's Cancer Center - Kuakini | Honolulu | Hawaii | United States | 96817 |
| 40 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 41 | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | United States | 60201 |
| 42 | NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | United States | 60026 |
| 43 | NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | United States | 60035 |
| 44 | UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | United States | 60451 |
| 45 | University of Chicago Medicine-Orland Park | Orland Park | Illinois | United States | 60462 |
| 46 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 47 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 48 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 49 | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | United States | 50309 |
| 50 | LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | United States | 71103 |
| 51 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 52 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 53 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 54 | Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | United States | 48114 |
| 55 | Saint Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 56 | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | United States | 48188 |
| 57 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 58 | Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | United States | 48118 |
| 59 | Hope Cancer Clinic | Livonia | Michigan | United States | 48154 |
| 60 | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | United States | 48154 |
| 61 | Huron Gastroenterology PC | Ypsilanti | Michigan | United States | 48106 |
| 62 | Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | United States | 48197 |
| 63 | Essentia Health - Deer River Clinic | Deer River | Minnesota | United States | 56636 |
| 64 | Essentia Health Cancer Center | Duluth | Minnesota | United States | 55805 |
| 65 | Essentia Health Hibbing Clinic | Hibbing | Minnesota | United States | 55746 |
| 66 | Essentia Health Sandstone | Sandstone | Minnesota | United States | 55072 |
| 67 | Essentia Health Virginia Clinic | Virginia | Minnesota | United States | 55792 |
| 68 | Saint Luke's Hospital | Chesterfield | Missouri | United States | 63017 |
| 69 | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | United States | 63141 |
| 70 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 71 | Siteman Cancer Center-South County | Saint Louis | Missouri | United States | 63129 |
| 72 | Siteman Cancer Center at Christian Hospital | Saint Louis | Missouri | United States | 63136 |
| 73 | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri | United States | 63376 |
| 74 | Cancer Partners of Nebraska - Pine Lake | Lincoln | Nebraska | United States | 68516 |
| 75 | Southeast Nebraska Cancer Center - 68th Street Place | Lincoln | Nebraska | United States | 68516 |
| 76 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 77 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
| 78 | Monmouth Medical Center Southern Campus | Lakewood | New Jersey | United States | 08701 |
| 79 | Monmouth Medical Center | Long Branch | New Jersey | United States | 07740 |
| 80 | Memorial Sloan Kettering Monmouth | Middletown | New Jersey | United States | 07748 |
| 81 | Memorial Sloan Kettering Bergen | Montvale | New Jersey | United States | 07645 |
| 82 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 83 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 84 | Community Medical Center | Toms River | New Jersey | United States | 08755 |
| 85 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 86 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 87 | Glens Falls Hospital | Glens Falls | New York | United States | 12801 |
| 88 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 89 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
| 90 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
| 91 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 92 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 93 | NYP/Weill Cornell Medical Center | New York | New York | United States | 10065 |
| 94 | Upstate Cancer Center at Oneida | Oneida | New York | United States | 13421 |
| 95 | Upstate Cancer Center at Oswego | Oswego | New York | United States | 13126 |
| 96 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 97 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
| 98 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 99 | Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma | United States | 73505 |
| 100 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 101 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 102 | Saint Francis Cancer Center | Greenville | South Carolina | United States | 29607 |
| 103 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 104 | Seattle Cancer Care Alliance at Overlake Medical Center | Bellevue | Washington | United States | 98004 |
| 105 | Seattle Cancer Care Alliance at Northwest Hospital | Seattle | Washington | United States | 98133 |
| 106 | West Virginia University Charleston Division | Charleston | West Virginia | United States | 25304 |
| 107 | Duluth Clinic Ashland | Ashland | Wisconsin | United States | 54806 |
| 108 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 109 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Elizabeth A Brem, Southwest Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2020-01256
- NCI-2020-01256
- S1918
- S1918
- U10CA180888