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Brief Title: A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes (The INSPIRE Study)

Phase II Study of Bladder-Sparing Chemoradiation With Durvalumab in Clinical Stage III, Node Positive Bladder Cancer (INSPIRE)

INTRODUCTION

  • Org Study ID: NCI-2019-08628
  • Secondary ID: NCI-2019-08628, EA8185, EA8185, U10CA180820
  • NTC ID: NCT04216290
  • Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY

This phase II trial studies the benefit of adding an immunotherapy drug called MEDI4736 (durvalumab) to standard chemotherapy and radiation therapy in treating bladder cancer which has spread to the lymph nodes. Drugs used in standard chemotherapy 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with durvalumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy and radiation therapy with the addition of durvalumab may work better in helping tumors respond to treatment compared to chemotherapy and radiation therapy alone. Patients with limited regional lymph node involvement may benefit from attempt at bladder preservation, and use of immunotherapy and systemic chemotherapy.

DETAILED DESCRIPTION

PRIMARY OBJECTIVE:

I. To compare the clinical complete response rate (cCR) after chemoradiotherapy (chemoRT) with or without durvalumab in node-positive bladder cancer patients.

SECONDARY OBJECTIVES:

I. To compare the toxicity profile in both arms using the Common Terminology Criteria for Adverse Events (CTCAE).

II. To estimate the progression-free survival (PFS) in both arms. III. To estimate overall survival (OS) post randomization in both arms. IV. To estimate the bladder intact event free survival (BIEFS) in both arms. V. To estimate the metastasis free survival (MFS) in both arms. VI. To estimate bladder cancer specific survival in both arms. VII. To estimate the complete clinical response duration in both arms. VIII. To estimate salvage cystectomy rates in both arms.

EXPLORATORY OBJECTIVE:

I. Planned subgroup analyses for clinical outcome (clinical complete response [CR] rate post chemoRT+/- durvalumab, MFS, OS, PFS) based on stratification factors.

TRANSLATIONAL OBJECTIVE:

I. To collect and bank tumor tissue and blood specimens at pre-and post-treatment with chemoRT +/- durvalumab to determine predictive or prognostic markers.

OUTLINE:

STEP 1 - REGISTRATION: Patients are assigned to 1 of 2 arms.

ARM A: Patients registered after completion of >= 3 cycles of induction chemotherapy proceed to Step 2 - Randomization.

ARM B: Chemotherapy naive patients receive 1 of 4 chemotherapy regimens: gemcitabine hydrochloride intravenously (IV) over 30-60 minutes on days 1 and 8 every 21 days for 3 cycles; carboplatin IV over 30-60 minutes on day 1 and gemcitabine hydrochloride IV over 30-60 minutes on days 1 and 8 every 21 days for 3 cycles; gemcitabine hydrochloride IV over 30-60 minutes on days 1 and 8 and cisplatin IV 30-60 minutes on day 1 every 21 days for 3 cycles; or methotrexate IV over 3 minutes, vinblastine sulfate IV over 3 minutes, doxorubicin hydrochloride IV over 5 minutes, and cisplatin IV over 30-60 minutes on day 1 every 14 days for 3 cycles. Cycles repeat in the absence of disease progression or unacceptable toxicity.

STEP 2 - RANDOMIZATION: Patients are randomized to 1 of 2 arms.

ARM C: Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients receive durvalumab IV over 60 minutes on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes twice weekly for 6 weeks; cisplatin IV over 30-60 minutes for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity.

ARM D: Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes twice weekly for 6 weeks; cisplatin IV over 30-60 minutes for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity.

STEP 3 - REGISTRATION (POST CONCURRENT CHEMORT +/- DURVALUMAB): Patients are assigned to 1 of 2 arms.

ARM E: Patients previously randomized to Arm C (chemoradiation and durvalumab) who achieve clinical CR or clinical benefit receive durvalumab IV over 60 minutes on day 1. Cycles repeat every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

ARM F: Patients previously randomized to Arm D who achieve clinical CR or clinical benefit, or patients previously randomized to Arm C with no clinical CR or clinical benefit undergo observation.

After completion of study treatment, patients are followed up every 12 weeks for 1 year, every 6 months for 1 year, and then annually for 1 year.

  • Overall Status
    Recruiting
  • Start Date
    August 25, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Clinical complete response (CR)

Primary Outcome 1 - Timeframe: Up to 6 years

CONDITION

  • Bladder Urothelial Carcinoma
  • Stage III Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8
  • Stage IIIB Bladder Cancer AJCC v8

ELIGIBILITY

Inclusion Criteria:
Step 1 (Registration) Inclusion

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of registration
Patient must have histologically proven pure or mixed urothelial cancer of the bladder
NOTE: Small cell carcinoma is excluded, however other variant histologies are permitted provided a component of urothelial carcinoma is present
Prior to receiving any induction chemotherapy, patient must have documented node-positive and non-metastatic disease (any T, any N, M0)
NOTE: Node positivity will be defined by the official interpretation of imaging studies by a radiologist. A positive lymph node is defined as lymph node (LN) >= 1.0 cm in short axis. LN Biopsy is not mandatory but encouraged if feasible and safe per physician discretion. Patients with a negative biopsy of nodes determined to be suspicious on imaging are not eligible. Please note that for non-muscle invasive disease on transurethral resection of a bladder tumor (TURBT), node-positive disease MUST be biopsy proven for patient to be eligible
Induction Chemotherapy Requirements
For patients registered to this protocol post-completion of induction systemic chemotherapy:
Patient must have received at least 3 cycles of induction chemotherapy (cisplatin-based chemotherapy OR non-cisplatin based chemotherapy) with no evidence of progressive disease (PD) on post-chemotherapy imaging. The end of last cycle of induction chemotherapy must be within 12 weeks of registration

- Patient who have received more than 3 cycles of induction systemic chemotherapy are also eligible
Patient must have had a CR, PR or SD to induction chemotherapy on standard imaging
NOTE: Patients who have only received 2 cycles of induction chemotherapy and demonstrated clinical response (complete response [CR] OR partial response [PR], OR stable disease [SD]) may be considered for enrollment only after consultation and approval by the study chair under exceptional circumstances where 3rd cycle cannot be delivered. Documentation of correspondences with the study chair must be kept on file. We encourage all patients to get 3 cycles of induction chemotherapy
For patients registered to this protocol prior to starting induction systemic chemotherapy:
Patient must agree to a planned treatment with 3 cycles of induction chemotherapy (physician's choice)

- Patient will again be restaged after completion of induction chemotherapy and prior to randomization to chemoRT +/- durvalumab

- Patient must have a CR, PR or SD to induction chemotherapy on standard imaging prior to randomization to chemoradiotherapy

- Patient must not have presence of concomitant active upper tract tumors or urethra tumors. History of previously adequately treated non-muscle invasive bladder cancer (NMIBC) are eligible; previously treated urothelial cancer or histological variant at any site outside of the urinary bladder are allowed, provided they have been Ta/T1/carcinoma in situ (CIS) and post treatment follow up imaging and endoscopic evaluation shows no evidence of disease

- Patients with previous exposure to immune checkpoint inhibitor for non-muscle invasive disease are eligible. If given for NMIBC, the last dose must have been completed > 12 months prior to registration
For patients registered on the study
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used

- All patients of childbearing potential must have a blood test or urine study within 14 days prior to 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)
For patients registered prior to induction chemotherapy only:
Patients must not expect to conceive or father children by using accepted and effected method(s) of contraception or by abstaining from sexual intercourse from the time of registration for the duration of their participation in the study and continue for at least 3 months after the last dose of protocol treatment

- Leukocytes >= 3,000/mcL (obtained < 14 days prior to registration) - Absolute neutrophil count (ANC) >= 1,500/mcL (obtained < 14 days prior to registration) - Hemoglobin >= 9 g/dL (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) (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) - Must have adequate renal function as evidenced by calculated (Cockcroft's formula) creatinine clearance or 24 hours actual creatinine clearance >= 30mL/min. The creatinine used to calculate the clearance result must have been obtained within 14 days prior to registration. Actual body weight, not ideal body weight, must be used in the calculation

- Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial

- 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. Site is encouraged to discuss with the study chair if needed prior to registration

- 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 IIB or better

- Step 2 (Randomization) Inclusion Criteria

- Patient must have an ECOG performance status of 0-2 at the time of randomization

- Patient must undergo selection of concurrent chemotherapy regimen
Patient must agree to undergo CT simulation and treatment planning. If this is the first case registered at the site, then a pre-treatment radiation therapy (RT) review will be required and will take up to 3 business days. The patient cannot start radiation treatment prior to successful completion of this pre-treatment review. Therefore, careful planning is necessary to meet the deadline of starting radiation within 20 business days of randomization and within 12 weeks of the end of induction chemotherapy
NOTE: Chemoradiotherapy should be planned to start up to 12 weeks after the end of induction chemotherapy, but after imaging and cystoscopic restaging, randomization, and any pretreatment radiation quality assurance (QA) that is required
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 must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse at least one week prior to the start of treatment and continue for at least 3 months after the last dose of the protocol treatment

- Leukocytes >= 3,000/mcL (obtained < 14 days prior to randomization) - Absolute neutrophil count (ANC) >= 1,500/mcL (obtained < 14 days prior to randomization) - Hemoglobin >= 9 g/dL (obtained < 14 days prior to randomization) - Platelets >= 100,000/mcL (obtained < 14 days prior to randomization) - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained < 14 days prior to randomization) - AST (SGOT)/ALT (SGPT) =< 2.5 x institutional ULN (obtained < 14 days prior to randomization) - Must have adequate renal function as evidenced by calculated (Cockcroft's formula) creatinine clearance or 24 hours actual creatinine clearance >= 30 mL/min. The creatinine used to calculate the clearance result must have been obtained within 14 days prior to randomization. Actual body weight, not ideal body weight, must be used in the calculation

- Step 3 (Post chemoRT+/- Durvalumab, prior to starting adjuvant Durvalumab versus [vs.] observation) Inclusion Criteria

- Patient must have evaluation to determine clinical outcome post chemoRT+/- durvalumab with imaging and cystoscopy with biopsy confirmation to ensure no progression and absence of >= T2 disease in the bladder

- Patient must have achieved either complete clinical response OR have demonstrated clinical benefit prior to continuing onto adjuvant durvalumab

- Patients who are to go on the adjuvant durvalumab arm must have recovered to at least grade 2 or less immune related adverse events (AE) prior to starting treatment except for immune related alopecia, clinically asymptomatic endocrinopathies. For patients who may have gotten immune related AEs during chemoRT+ durvalumab, registration could be delayed up to additional 4 weeks to ensure recovery to at least grade 2 or lower prior to starting adjuvant therapy. However patients with durvalumab related AEs that require permanent discontinuation of durvalumab will not continue on the adjuvant treatment regardless of the response

- ANC >= 1,000 mcL (within 4 weeks of start of day 1 [D1] of adjuvant treatment)

- Hemoglobin >= 8 g/dL (within 4 weeks of start of D1 of adjuvant treatment)

- Platelets >= 70,000 mcL (within 4 weeks of start of D1 of adjuvant treatment)

- Patient on the chemoRT arm must have achieved either complete clinical response OR have demonstrated clinical benefit prior to be placed on the observation alone arm
Exclusion Criteria:
Step 1 (Registration) Exclusion

- Patient must not have received any previous radiation therapy to the pelvic area
For patients with autoimmune conditions, patient must not have history of prior documented autoimmune disease within 2 years prior to registration
NOTE: Patient with vitiligo, Grave's disease, eczema or psoriasis (not requiring systemic treatment within 2 years prior to registration) are not excluded. Patients with history of completely resolved childhood asthma or atopy are not excluded. Patients with asthma not requiring more than 10 mg/d or equivalent of prednisone are not excluded. Patients with well-controlled hypothyroidism on thyroxine replacement will be eligible as well. Patients with known history of hypoadrenalism on maintenance steroids will be eligible. Patients with type I diabetes mellitus will be eligible, provided their disease is well controlled. History of autoimmune related alopecia is also not an exclusion criteria

- Patient with active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) are not eligible

- Patient with a history of and/or confirmed pneumonitis are not eligible

- Patient with a history of primary immunodeficiency are not eligible

- Patient with history of allogeneic organ transplant are not eligible

- Patient must not have clinically significant liver disease that precludes patient from treatment regimens prescribed on the study (including, but not limited to, active viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease)
Patient must not have any unresolved toxicity (National Cancer Institute [NCI] CTCAE grade >= 2) from previous anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values
NOTE: Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study chair

- NOTE: Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study chair. Documentation of correspondences with the study chair must be kept on file

- Step 2 (Randomization) Exclusion Criteria
Patient must have no signs of progression (CR/PR or SD) based on restaging imaging and cystoscopy after completion of induction chemotherapy, which consists of:
Computed tomography (CT) chest, abdomen, or pelvis. Magnetic resonance imaging (MRI) pelvis can be used instead of CT per treating physician discretion. The imaging must be done within 6 weeks prior to randomization

- Cystoscopic evaluation and attempt to perform maximal transurethral resection of bladder tumor (TURBT) performed by the participating urologist ideally within 8 weeks but up to 10 weeks is allowed prior to randomization. If maximal TURBT is not possible for medical reasons, the enrollment must be discussed and approved with the study chair. Documentation of correspondences with the study chair must be kept on file

- Patients who achieve CR upon cystoscopy per urologist with no visible tumor (i.e. no need for additional TURBT), are allowed to proceed in the study as adequate resection with no residual disease in bladder
For patients with autoimmune conditions: Patient must not have a history of active or prior documented autoimmune disease within 2 years prior to registration
NOTE: Patient with vitiligo, Grave's disease, eczema or psoriasis (not requiring systemic treatment within 2 years prior to registration) are not excluded. Patients with history of completely resolved childhood asthma or atopy are not excluded. Patients with asthma not requiring more than 10mg/d or equivalent of prednisone are not excluded. Patient with well-controlled hypothyroidism on thyroxine replacement will be eligible as well. Patients with known history of hypoadrenalism on maintenance steroids will be eligible. Patients with type I diabetes mellitus (DM) will be eligible, provided their dise

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Monika Joshi

Role: Principal Investigator

Affiliation: ECOG-ACRIN Cancer Research Group

Overall Contact

Name: Monika Joshi

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Porter Adventist Hospital
Denver, Colorado 80210
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-788-3528
emede1@lsuhsc.edu
Facility: Littleton Adventist Hospital
Littleton, Colorado 80122
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Parker Adventist Hospital
Parker, Colorado 80138
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-241-6727
stephanie.couch@stjoeshealth.org
Facility: Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
CancerTrials@EssentiaHealth.org
Facility: Carle on Vermilion
Danville, Illinois 61832
United States
Status: Recruiting Contact: Principal Investigator
Joshua Lukenbill
218-786-3308
CanRsrchStudies@providence.org
Facility: Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Principal Investigator
Scott E. Delacroix
800-600-3606
kmertz-rivera@gibbscc.org
Facility: Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569
CancerTrials@EssentiaHealth.org
Facility: Crossroads Cancer Center
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Principal Investigator
Scott E. Delacroix
800-600-3606
CancerTrials@EssentiaHealth.org
Facility: Edward Hines Jr VA Hospital
Hines, Illinois 60141
United States
Status: Recruiting Contact: Principal Investigator
Sarah J. Sinclair
314-251-7066
Facility: Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569
Facility: Loyola University Medical Center
Maywood, Illinois 60153
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
314-996-5569
Facility: Springfield Clinic
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Memorial Medical Center
Springfield, Illinois 62781
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Carle Cancer Center
Urbana, Illinois 61801
United States
Status: Recruiting Contact: Principal Investigator
Bret E. Friday

Facility: Mary Greeley Medical Center
Ames, Iowa 50010
United States
Status: Recruiting Contact: Principal Investigator
Bret E. Friday

Facility: McFarland Clinic PC - Ames
Ames, Iowa 50010
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
United States
Status: Recruiting Contact: Principal Investigator
Bret E. Friday

Facility: Broadlawns Medical Center
Des Moines, Iowa 50314
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Principal Investigator
Brian C. Baumann

Facility: Eastern Maine Medical Center
Bangor, Maine 04401
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller

Facility: Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Brian C. Baumann

Facility: IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Principal Investigator
Jay W. Carlson

Facility: IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Principal Investigator
Brian C. Baumann

Facility: Ascension Saint John Hospital
Detroit, Michigan 48236
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller

Facility: Saint Mary Mercy Hospital
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller

Facility: Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
United States
Status: Recruiting Contact: Principal Investigator
Neda Hashemi Sadraei

Facility: IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Status: Recruiting Contact: Principal Investigator
Abhishek Tripathi

Facility: Miller-Dwan Hospital
Duluth, Minnesota 55805
United States
Status: Recruiting Contact: Principal Investigator
Alison K. Conlin

Facility: Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Essentia Health Sandstone
Sandstone, Minnesota 55072
United States
Status: Recruiting Contact: Principal Investigator
Monika Joshi

Facility: Essentia Health Virginia Clinic
Virginia, Minnesota 55792
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Parkland Health Center - Farmington
Farmington, Missouri 63640
United States
Status: Recruiting Contact: Principal Investigator
Bret E. Friday

Facility: Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: N/A
Facility: Siteman Cancer Center-South County
Saint Louis, Missouri 63129
United States
Status: Recruiting Contact: N/A
Facility: Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Status: Recruiting Contact: N/A
Facility: Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
United States
Status: Recruiting Contact: N/A
Facility: Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: N/A
Facility: Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
United States
Status: Recruiting Contact: N/A
Facility: Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Status: Recruiting Contact: N/A
Facility: Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Status: Recruiting Contact: N/A
Facility: Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
United States
Status: Recruiting Contact: N/A
Facility: Bozeman Deaconess Hospital
Bozeman, Montana 59715
United States
Status: Recruiting Contact: N/A
Facility: University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
United States
Status: Recruiting Contact: N/A
Facility: Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Status: Recruiting Contact: N/A
Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: N/A
Facility: Providence Portland Medical Center
Portland, Oregon 97213
United States
Status: Recruiting Contact: N/A
Facility: Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
Status: Recruiting Contact: N/A
Facility: Spartanburg Medical Center
Spartanburg, South Carolina 29303
United States
Status: Recruiting Contact: N/A
Facility: Duluth Clinic Ashland
Ashland, Wisconsin 54806
United States
Status: Recruiting Contact: N/A
Facility: Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
United States
Status: Recruiting Contact: N/A