Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Study Details
Study Description
Brief Summary
This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine 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. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVES:
- To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, adriamycin, cisplatin (aMVAC) alone or in combination with MEDI4736 (durvalumab). (Cisplatin eligible patients [Arms A and B]) II. Evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pathologic complete response [pCR], pT0N0/ Nx). (Cisplatin ineligible patients [Arm C]).
SECONDARY OBJECTIVES:
- To assess pathologic complete response (pCR) at surgery. (Cisplatin eligible cohort) II. Event-free survival (EFS) will be evaluated for the cisplatin ineligible cohort as a secondary endpoint. (Cisplatin ineligible cohort) III. Overall survival in all, and by post chemotherapy response (ypCR, yp =< T1N0, yp >= T2Nany). (All patients) IV. To evaluate disease-free survival (DFS) in each arm separately. (All patients) V. To evaluate cancer-specific survival of patients in each arm separately. (All patients) VI. To evaluate renal function outcomes following systemic treatment and following surgery ([RNU) in each arm separately. (All patients) VII. To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with MEDI4736 (durvalumab) prior to RNU. (All patients)
OUTLINE: Patients eligible for cisplatin are randomized to Arms A or B. Patients ineligible for cisplatin are assigned to Arm C.
ARM A: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.
ARM B: Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.
ARM C: Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery.
After completion of study treatment, patients are followed up within 30 days and then every 3-6 months for up to 5 years from study entry.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A (durvalumab, chemotherapy) Patients receive durvalumab IV over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. |
Drug: Cisplatin
Given IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given Iv
Other Names:
Biological: Durvalumab
Given IV
Other Names:
Drug: Methotrexate
Given IV
Other Names:
Biological: Pegfilgrastim
Given via injection
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Vinblastine Sulfate
Given Iv
Other Names:
|
| Active Comparator: Arm B (chemotherapy) Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. |
Drug: Cisplatin
Given IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given Iv
Other Names:
Drug: Methotrexate
Given IV
Other Names:
Biological: Pegfilgrastim
Given via injection
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Vinblastine Sulfate
Given Iv
Other Names:
|
| Experimental: Arm C (durvalumab, gemcitabine hydrochloride) Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. |
Biological: Durvalumab
Given IV
Other Names:
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo surgery
|
Outcome Measures
Primary Outcome Measures
- Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B) [From randomization to the earliest of systemic recurrence, disease progression, or death from any cause, assessed up to 5 years]
Defined as disease recurring outside of the bladder, urethra, or contralateral upper tract.
- Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C) [At surgery]
Will assess pathologic complete response at surgery (pCR, pT0N0/Nx) by local pathology review. Patients who drop out prior to surgery or who have unknown response status will be considered as non-responders.
Secondary Outcome Measures
- pCR (Cisplatin-eligible cohort: Arms A and B) [Up to 5 years]
- EFS (cisplatin-ineligible cohort: Arm C) [From randomization to the earliest of systemic recurrence, disease progression, or death from any cause, assessed up to 5 years]
Will be characterized using the Kaplan-Meier method.
- Overall survival (OS) (All Patients) [From registration to death from any cause, assessed up to 5 years]
OS will be evaluated by arm, post chemotherapy response (ypCR, stage yp =< T1N0, yp >= T2N0), as well as stage (ypCR and > ypCR) within and across treatment arms. Will be estimated using Kaplan-Meier method.
- Urothelial cancer-free survival or disease-free survival (All Patients) [From the date of surgery to the earlier of a return of upper tract urothelial cancer (UTUC) or death from any cause, assessed up to 5 years]
A return of UTUC includes non-muscle invasive recurrences, pathologic T2 or higher muscle-invasive recurrences specifically in the urinary tract, metastatic disease outside the urinary tract, or death. Patients alive without documented UTUC will be censored at the date of last disease assessment.
- Cancer-specific survival (All Patients) [From registration to death due to cancer; deaths due to other causes will be counted as competing events, assessed up to 5 years]
Will be analyzed using Gray's method and cumulative incidence estimates will be reported.
- Renal function outcomes following systemic treatment and following radical nephroureterectomy (All Patients) [Post chemotherapy and post surgery]
The proportion of patients with renal insufficiency (creatinine [CrCl] < 60 ml/min) post chemotherapy and post nephroureterectomy as well as the proportion of patients with renal function improvement (CrCl < 60 ml/min at baseline and CrCl >= 60 ml/min on study) will be reported along with exact binomial confidence intervals. The distribution of changes in renal function post chemotherapy as well as post surgery from baseline will also be reported. The analysis of renal function outcomes will be performed among patients who receive at least one dose of study therapy.
- Incidence of adverse events (All Patients) [Up to 30 days post surgery]
Toxicity will be evaluated in all treated patients.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
STEP 1 REGISTRATION AND RANDOMIZATION
-
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
-
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 60 days prior to registration with one of the following:
-
Upper urinary tract mass on cross-sectional imaging or
-
Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology
-
NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice
-
Leukocytes >= 3,000/mcL (obtained =< 14 days prior to registration)
-
Platelets >= 100,000/mcL (obtained =< 14 days prior to registration)
-
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN for patients with Gilbert's disease) (obtained =< 14 days prior to registration)
-
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 14 days prior to registration)
-
Hemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration)
-
NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator
-
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
-
NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months
-
NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count >= 250 cells/mcL within 7 days of registration
-
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
-
NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated
-
Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
-
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
-
Patient must have a body weight of > 30 kg
-
Patient must have a life expectancy of >= 12 weeks
-
Patient must have a creatinine clearance > 15 ml/min as by Crockroft-Gault or 24-hour creatinine clearance within 28 days prior to registration
-
NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and hearing loss in keeping with SOC cisplatin contraindications. Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B
-
Patients that meet the following criteria will be assigned to the cisplatin-ineligible Arm C:
-
Creatinine clearance of > 15 ml/min and =< 50 ml/min
-
Patient must have an absolute neutrophil count (ANC) >= 1,000/mcL obtained =< 14 days prior to registration
-
Patient must have ECOG performance status 0-2
-
Patients that meet the following criteria will be randomized to cisplatin-eligible Arm A or Arm B:
-
Patient must have an absolute neutrophil count (ANC) >= 1,500/mcL obtained =< 14 days prior to randomization
-
Patient must have ECOG performance status 0-1
-
Patient must have left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within 28 days prior to randomization
-
Patient must not have peripheral neuropathy >= grade 2 or hearing loss
= grade 3
Exclusion Criteria:
-
Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma
-
Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, 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)
-
Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment
-
Patient must have no evidence of metastatic disease or clinically enlarged lymph nodes (>= 1.0 cm short axis) on imaging required within 28 days prior to registration (solitary slightly enlarged lymph node with negative biopsy is allowed)
-
NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness should also undergo baseline bone scans to evaluate for bone metastasis
-
Patient must not have another active (or within 2 years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =< Gleason 3+4) on surveillance or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat
-
NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed
-
Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last 3 months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements
-
Patient must not have received prior radiation therapy to >= 25% of the bone marrow for other diseases
-
Patient must not have received prior systemic anthracycline therapy
-
NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible
-
Patient must not have an active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration or a history of inflammatory bowel disease (inflammatory bowel disease [IBD], colitis, or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome or immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diverticulosis, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible
-
Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of MEDI4736 (MEDI4736 (durvalumab). The following are exceptions to this criterion:
-
Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection
-
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment
-
Steroids as premedications for hypersensitivity reactions (e.g. computed tomography [CT] scan premedication)
-
Patient must not have a concomitant primary urothelial carcinoma of the bladder and/or urethra
-
NOTE: Patients in whom concomitant or prior bladder/urethra predominant (>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed
-
Patient must not have prior history of muscle-invasive urothelial carcinoma with or without systemic chemotherapy (T2-4a and/or N1) within 2 years prior to registration
-
NOTE: Patients who have no evidence of disease (NED) for more than 2 years from the latest therapy (surgery, radiation, chemotherapy, or clinical trial) are eligible
-
Patient must not have received live attenuated vaccine within 30 days prior to the first dose of MEDI4736 (durvalumab), while on protocol treatment and within 30 days after the last dose of MEDI4736 (durvalumab)
-
Patient must not have had a major surgical procedure (as defined by the Investigator) within 28 days prior to registration
-
Patient must not have a history of allogenic organ transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mercy Hospital Fort Smith | Fort Smith | Arkansas | United States | 72903 |
| 2 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 3 | Sutter Auburn Faith Hospital | Auburn | California | United States | 95602 |
| 4 | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | United States | 94704 |
| 5 | Palo Alto Medical Foundation-Camino Division | Mountain View | California | United States | 94040 |
| 6 | Palo Alto Medical Foundation Health Care | Palo Alto | California | United States | 94301 |
| 7 | Sutter Roseville Medical Center | Roseville | California | United States | 95661 |
| 8 | California Pacific Medical Center-Pacific Campus | San Francisco | California | United States | 94115 |
| 9 | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California | United States | 94086 |
| 10 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
| 11 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 12 | Poudre Valley Hospital | Fort Collins | Colorado | United States | 80524 |
| 13 | Cancer Care and Hematology-Fort Collins | Fort Collins | Colorado | United States | 80528 |
| 14 | UCHealth Greeley Hospital | Greeley | Colorado | United States | 80631 |
| 15 | UCHealth Highlands Ranch Hospital | Highlands Ranch | Colorado | United States | 80129 |
| 16 | Medical Center of the Rockies | Loveland | Colorado | United States | 80538 |
| 17 | MedStar Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 18 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
| 19 | Saint Anthony's Health | Alton | Illinois | United States | 62002 |
| 20 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
| 21 | Loyola Center for Health at Burr Ridge | Burr Ridge | Illinois | United States | 60527 |
| 22 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 23 | Memorial Hospital of Carbondale | Carbondale | Illinois | United States | 62902 |
| 24 | SIH Cancer Institute | Carterville | Illinois | United States | 62918 |
| 25 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 26 | Centralia Oncology Clinic | Centralia | Illinois | United States | 62801 |
| 27 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 28 | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | United States | 62526 |
| 29 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 30 | Illinois CancerCare-Dixon | Dixon | Illinois | United States | 61021 |
| 31 | Carle Physician Group-Effingham | Effingham | Illinois | United States | 62401 |
| 32 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 33 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
| 34 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
| 35 | Western Illinois Cancer Treatment Center | Galesburg | Illinois | United States | 61401 |
| 36 | Loyola Medicine Homer Glen | Homer Glen | Illinois | United States | 60491 |
| 37 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 38 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 39 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 40 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 41 | Marjorie Weinberg Cancer Center at Loyola-Gottlieb | Melrose Park | Illinois | United States | 60160 |
| 42 | Good Samaritan Regional Health Center | Mount Vernon | Illinois | United States | 62864 |
| 43 | Cancer Care Center of O'Fallon | O'Fallon | Illinois | United States | 62269 |
| 44 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 45 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
| 46 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 47 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 48 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
| 49 | Valley Radiation Oncology | Peru | Illinois | United States | 61354 |
| 50 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
| 51 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 52 | Springfield Clinic | Springfield | Illinois | United States | 62702 |
| 53 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 54 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 55 | Illinois CancerCare - Washington | Washington | Illinois | United States | 61571 |
| 56 | Reid Health | Richmond | Indiana | United States | 47374 |
| 57 | Mary Greeley Medical Center | Ames | Iowa | United States | 50010 |
| 58 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 59 | University of Iowa Healthcare Cancer Services Quad Cities | Bettendorf | Iowa | United States | 52722 |
| 60 | McFarland Clinic PC-Boone | Boone | Iowa | United States | 50036 |
| 61 | McFarland Clinic PC-Trinity Cancer Center | Fort Dodge | Iowa | United States | 50501 |
| 62 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 63 | McFarland Clinic PC-Jefferson | Jefferson | Iowa | United States | 50129 |
| 64 | McFarland Clinic PC-Marshalltown | Marshalltown | Iowa | United States | 50158 |
| 65 | Central Care Cancer Center - Garden City | Garden City | Kansas | United States | 67846 |
| 66 | Central Care Cancer Center - Great Bend | Great Bend | Kansas | United States | 67530 |
| 67 | East Jefferson General Hospital | Metairie | Louisiana | United States | 70006 |
| 68 | LSU Healthcare Network / Metairie Multi-Specialty Clinic | Metairie | Louisiana | United States | 70006 |
| 69 | Harold Alfond Center for Cancer Care | Augusta | Maine | United States | 04330 |
| 70 | MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford | Biddeford | Maine | United States | 04005 |
| 71 | MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford | Sanford | Maine | United States | 04073 |
| 72 | Maine Medical Partners - South Portland | South Portland | Maine | United States | 04106 |
| 73 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 74 | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 75 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 76 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 77 | Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | United States | 48114 |
| 78 | Saint Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 79 | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | United States | 48188 |
| 80 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 81 | Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | United States | 48118 |
| 82 | Newland Medical Associates-Clarkston | Clarkston | Michigan | United States | 48346 |
| 83 | Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | United States | 48503 |
| 84 | Genesee Hematology Oncology PC | Flint | Michigan | United States | 48503 |
| 85 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 86 | Hope Cancer Clinic | Livonia | Michigan | United States | 48154 |
| 87 | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | United States | 48154 |
| 88 | Newland Medical Associates-Pontiac | Pontiac | Michigan | United States | 48341 |
| 89 | Huron Gastroenterology PC | Ypsilanti | Michigan | United States | 48106 |
| 90 | Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | United States | 48197 |
| 91 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 92 | Minnesota Oncology - Burnsville | Burnsville | Minnesota | United States | 55337 |
| 93 | Cambridge Medical Center | Cambridge | Minnesota | United States | 55008 |
| 94 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 95 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 96 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 97 | Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota | United States | 55369 |
| 98 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
| 99 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
| 100 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 101 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 102 | Health Partners Inc | Minneapolis | Minnesota | United States | 55454 |
| 103 | Monticello Cancer Center | Monticello | Minnesota | United States | 55362 |
| 104 | New Ulm Medical Center | New Ulm | Minnesota | United States | 56073 |
| 105 | Fairview Northland Medical Center | Princeton | Minnesota | United States | 55371 |
| 106 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
| 107 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
| 108 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 109 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 110 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 111 | Saint Francis Regional Medical Center | Shakopee | Minnesota | United States | 55379 |
| 112 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
| 113 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 114 | Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
| 115 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
| 116 | Fairview Lakes Medical Center | Wyoming | Minnesota | United States | 55092 |
| 117 | Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri | United States | 63011 |
| 118 | Central Care Cancer Center - Bolivar | Bolivar | Missouri | United States | 65613 |
| 119 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 120 | Southeast Cancer Center | Cape Girardeau | Missouri | United States | 63703 |
| 121 | Parkland Health Center - Farmington | Farmington | Missouri | United States | 63640 |
| 122 | Capital Region Southwest Campus | Jefferson City | Missouri | United States | 65109 |
| 123 | Freeman Health System | Joplin | Missouri | United States | 64804 |
| 124 | Mercy Hospital Joplin | Joplin | Missouri | United States | 64804 |
| 125 | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | United States | 65401 |
| 126 | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | United States | 65401 |
| 127 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
| 128 | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri | United States | 63109 |
| 129 | Mercy Hospital South | Saint Louis | Missouri | United States | 63128 |
| 130 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 131 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 132 | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | United States | 63670 |
| 133 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
| 134 | CoxHealth South Hospital | Springfield | Missouri | United States | 65807 |
| 135 | Missouri Baptist Sullivan Hospital | Sullivan | Missouri | United States | 63080 |
| 136 | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | United States | 63127 |
| 137 | Mercy Hospital Washington | Washington | Missouri | United States | 63090 |
| 138 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 139 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 140 | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | United States | 28328 |
| 141 | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | United States | 27534 |
| 142 | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | United States | 28546 |
| 143 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 144 | Dayton Physicians LLC-Miami Valley South | Centerville | Ohio | United States | 45459 |
| 145 | Miami Valley Hospital South | Centerville | Ohio | United States | 45459 |
| 146 | Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
| 147 | Dayton Physician LLC-Miami Valley Hospital North | Dayton | Ohio | United States | 45415 |
| 148 | Miami Valley Hospital North | Dayton | Ohio | United States | 45415 |
| 149 | Armes Family Cancer Center | Findlay | Ohio | United States | 45840 |
| 150 | Dayton Physicians LLC-Atrium | Franklin | Ohio | United States | 45005 |
| 151 | Greater Dayton Cancer Center | Kettering | Ohio | United States | 45409 |
| 152 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
| 153 | Springfield Regional Cancer Center | Springfield | Ohio | United States | 45504 |
| 154 | Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma | United States | 73505 |
| 155 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 156 | Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | United States | 73120 |
| 157 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 158 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 159 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 160 | UT Southwestern/Simmons Cancer Center-Fort Worth | Fort Worth | Texas | United States | 76104 |
| 161 | UT Southwestern Clinical Center at Richardson/Plano | Richardson | Texas | United States | 75080 |
| 162 | ThedaCare Regional Cancer Center | Appleton | Wisconsin | United States | 54911 |
| 163 | Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | United States | 53105 |
| 164 | Aurora Health Care Germantown Health Center | Germantown | Wisconsin | United States | 53022 |
| 165 | Aurora Cancer Care-Grafton | Grafton | Wisconsin | United States | 53024 |
| 166 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 167 | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | United States | 53142 |
| 168 | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | United States | 54143 |
| 169 | Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | United States | 53209 |
| 170 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 171 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 172 | ProHealth D N Greenwald Center | Mukwonago | Wisconsin | United States | 53149 |
| 173 | Cancer Center of Western Wisconsin | New Richmond | Wisconsin | United States | 54017 |
| 174 | ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | United States | 53066 |
| 175 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 176 | Aurora Cancer Care-Racine | Racine | Wisconsin | United States | 53406 |
| 177 | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | United States | 53081 |
| 178 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 179 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 180 | ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
| 181 | UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | United States | 53188 |
| 182 | Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | United States | 53226 |
| 183 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jean H Hoffman-Censits, ECOG-ACRIN Cancer Research Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2020-09850
- NCI-2020-09850
- EA8192
- EA8192
- U10CA180820