Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body

NCT ID: NCT06470243

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2032-04-30

Brief Summary

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This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, 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. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.

Detailed Description

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PRIMARY OBJECTIVES:

I. To compare radiographic progression free survival (rPFS) between the two treatment arms in the subset of aggressive variant prostate cancer - molecular-pathologic signature (AVPC-MS)-positive participants.

II. If the AVPC-MS positive test is statistically significant, test in AVPC-MS negative participants whether the combination of carboplatin and cabazitaxel improves rPFS.

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) between the two treatment arms, stratified by AVPC-MS positive versus (vs.) negative.

II. To compare response rates for prostate specific antigen (PSA), total alkaline phosphatase, and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the two treatment arms, stratified by AVPC-MS positive vs. negative.

III. To compare rPFS between the two treatment arms for the full trial. IV. To compare rPFS between the two treatment arms for the AVPC-MS negative group in the absence of a positive treatment effect in the AVPC-MS positive group.

V. To compare progression free survival (PFS) between the two treatment arms, stratified by AVPC-MS positive vs. negative.

VI. To compare toxicities between the two arms in participants who receive any treatment on study.

BANKING OBJECTIVES:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive cabazitaxel intravenously (IV) over 60 minutes on day 1 of each cycle and prednisone orally (PO) twice daily (BID) on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.

All patients undergo blood sample collection, bone scan, computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) throughout the trial and chest radiography (x-ray) before randomization.

After completion of study treatment, patients are followed every 12 weeks for 1 year after randomization, and then every 26 weeks for up to 4 years after randomization or until death, whichever occurs first.

Conditions

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Castration-Resistant Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 (cabazitaxel, prednisone)

Patients receive cabazitaxel IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Bone Scan

Intervention Type PROCEDURE

Undergo bone scan

Cabazitaxel

Intervention Type DRUG

Given IV

Chest Radiography

Intervention Type PROCEDURE

Undergo chest x-ray

Computed Tomography

Intervention Type PROCEDURE

Undergo CT or PET/CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Prednisone

Intervention Type DRUG

Given PO

Arm 2 (cabazitaxel, carboplatin, prednisone)

Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Bone Scan

Intervention Type PROCEDURE

Undergo bone scan

Cabazitaxel

Intervention Type DRUG

Given IV

Carboplatin

Intervention Type DRUG

Given IV

Chest Radiography

Intervention Type PROCEDURE

Undergo chest x-ray

Computed Tomography

Intervention Type PROCEDURE

Undergo CT or PET/CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Prednisone

Intervention Type DRUG

Given PO

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Bone Scan

Undergo bone scan

Intervention Type PROCEDURE

Cabazitaxel

Given IV

Intervention Type DRUG

Carboplatin

Given IV

Intervention Type DRUG

Chest Radiography

Undergo chest x-ray

Intervention Type PROCEDURE

Computed Tomography

Undergo CT or PET/CT

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Prednisone

Given PO

Intervention Type DRUG

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Bone Scintigraphy Jevtana RPR-116258A RPR116258A Taxoid XRP6258 TXD258 XRP-6258 XRP6258 Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 JM8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Chest X-ray CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT .delta.1-Cortisone 1, 2-Dehydrocortisone Adasone Cortancyl Dacortin DeCortin Decortisyl Decorton Delta 1-Cortisone Delta-Dome Deltacortene Deltacortisone Deltadehydrocortisone Deltasone Deltison Deltra Econosone Lisacort Meprosona-F Metacortandracin Meticorten Ofisolona Orasone Panafcort Panasol-S Paracort Perrigo Prednisone PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Predniment Prednisone Intensol Prednisonum Prednitone Promifen Rayos Servisone SK-Prednisone

Eligibility Criteria

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Inclusion Criteria

* STEP 1 SCREENING REGISTRATION: NOTE: All participants must have biopsy tissue submitted to MD Anderson Cancer Center prior to randomization for alteration assessment. Participants must have determination of their AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status from central assessment by the MD Anderson Clinical Pathology Laboratory using Clinical Laboratory Improvement Act (CLIA) certified immunohistochemistry (IHC) assays for TP53, RB1 and PTEN. In addition, while not mandated, CLIA certified next generation sequencing (NGS) of tumor deoxyribonucleic acid (DNA) and/or circulating tumor derived DNA (ctDNA) assessment of AVPC-MS marker status will be collected from participants for whom it is available
* STEP 1 SCREENING REGISTRATION: Participants must have a histologically confirmed diagnosis of prostate cancer at the time of step 1 registration
* STEP 1 SCREENING REGISTRATION: Participants must have castrate-resistant prostate cancer and metastatic disease by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node)
* STEP 1 SCREENING REGISTRATION: Participants may have received any prior therapy, but one must be docetaxel or contain docetaxel in either the castrate-sensitive and/or castrate resistant disease state
* STEP 1 SCREENING REGISTRATION: Participants must be ≥ 18 years of age at the time of step 1 screening registration
* STEP 1 SCREENING REGISTRATION: Participants must have solid tumor biopsy material (formalin-fixed paraffin-embedded (FFPE) tissue blocks and/or 10 cut slides on four-micron thick unstained positive charged slides of FFPE tissue) available for submission for alterations in TP53, RB1 and PTEN by IHC using CLIA certified assays in the MD Anderson Clinical Pathology Laboratory. This specimen is required for central assessment of the AVPC-MSIHC regardless of whether the site has already locally evaluated the AVPC-MS status
* STEP 1 SCREENING REGISTRATION: Tumor samples submitted for analysis must have been collected within 12 months prior to step 1 screening registration. Samples from metastatic lesions collected in the castrate-resistant disease state are preferable but not mandatory. Samples obtained during the hormone-naive disease state are acceptable if collected within 12 months of step 1 screening registration. If more than one tumor sample exists, the sample obtained closest to the date of registration should be submitted to MDACC for analysis

* NOTE: Sites will receive an email from Southwest Oncology Group (SWOG) Statistics and Data Management Center containing participant results of Aggressive Variant Prostate Cancer Molecular Signature (AVPC-MS) assessment within 5-12 business days after tissue submission to MD Anderson Clinical Pathology Laboratory. The participant's AVPC-MS signature result (positive or negative) is required BEFORE randomization on to step 2. If sites receive a non-evaluable AVPC-MS signature result, SWOG Statistics and Data Management Center will provide instructions for resubmission
* STEP 1 SCREENING REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* STEP 1 SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. Documentation of informed consent via remote consent is allowed

* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
* STEP 2 RANDOMIZATION: NOTE: Participants must be registered to step 2 randomization within 70 days after registration to step 1. Participants must plan to start protocol therapy no more than 14 days after step 2 randomization
* STEP 2 RANDOMIZATION: Participants must have castrate levels of testosterone with a baseline level \< 50ng/dL within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants must have evidence for metastatic prostate cancer by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node). Visceral and/or soft-tissue metastases must be ≥ 1.0 cm in diameter and lymph nodes must be \> 1.5 cm diameter in the short axis. Scans must be obtained within 28 days prior to randomization

* NOTE: All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
* STEP 2 RANDOMZIATION: Participants must have progressive disease (PD) in the opinion of the treating investigator according to any of the following criteria

* Progression in measurable disease (RECIST 1.1 criteria). Patient with measurable disease must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) \[CT scan thickness no greater than 5 mm\] or magnetic resonance imaging (MRI). Lymph nodes should be ≥ 15 mm in short axis. Previously irradiated lesions, primary prostate lesion and bone lesions will be considered non-measurable disease
* Progression in bone as evidenced by:

* Appearance of 2 or more new bone lesions on bone scan (BS). If equivocal, they must be confirmed by other imaging modalities (CT; MRI), and/or repeat BS \> 4 weeks later
* Appearance of a new lytic lesion(s) and/or increasing size of an existing lesion by CT/MRI, since AVPC tumors may produce lytic bone lesions that are not detected on conventional bone scans
* Rising prostate-specific antigen (PSA) defined (Prostate Cancer Working Group 2 \[PCWG2\]) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart. The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA measure is required to be taken and be greater than the 2nd measure. In case of progression based on rising PSA only, the first rising PSA (measure 2) must be obtained within 6 months of initiation of androgen receptor (AR) targeted therapy (≤ 6 months)
* Clinical progression. Increasing symptoms unequivocally attributed to disease progression as judged by the treating physician
* STEP 2 RANDOMIZATION: Participants must not have received prior cabazitaxel or carboplatin
* STEP 2 RANDOMIZATION: Participants must not be receiving treatment on another therapeutic clinical trial at the time of randomization. Chemotherapies, bone targeting therapies, immunotherapies and clinical trial agents must be discontinued ≥ 21 days prior to randomization. Stereotactic radiation (SART) must be discontinued ≥ 3 days prior to randomization
* STEP 2 RANDOMIZATION: Participants must not be receiving radiation therapy or kyphoplasty-vertebroplasty within 14 days prior to randomization or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants must not have untreated fractures and/or cord compression
* STEP 2 RANDOMIZATION: Participants must not have symptomatic uncontrolled brain metastases. Properly treated brain metastases (i.e., with stereotactic radiation) within 14 days are allowed
* STEP 2 RANDOMIZATION: Participants must have Zubrod performance status of 0 - 2 within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants must have a complete medical history and physical exam within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Platelets ≥ 100 x 10\^3/uL (unless clinical evidence of bone marrow infiltration by tumor in which case \> 75 x 10\^3/uL are allowed) (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome or if the participant has liver metastases and/or acute tumor associated illness \< 4x ULN (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (or if participant has liver metastases and/or acute tumor-associated illness, ≤ 4x institutional ULN) (within 28 days prior to step 2 randomization)
* STEP 2 REGISTRATION: Participants must have a calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants with peripheral neuropathy must have ≤ grade 2 peripheral neuropathy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen
* STEP 2 RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen
* STEP 2 RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* STEP 2 RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Corn

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group - Rogers

Rogers, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status RECRUITING

Tibor Rubin VA Medical Center

Long Beach, California, United States

Site Status RECRUITING

Beebe Medical Center

Lewes, Delaware, United States

Site Status RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status RECRUITING

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Site Status RECRUITING

SIH Cancer Institute

Carterville, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Valley Radiation Oncology

Peru, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Memorial Medical Center

Springfield, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

Reid Health

Richmond, Indiana, United States

Site Status RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Christiana Care - Union Hospital

Elkton, Maryland, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Site Status RECRUITING

Caro Cancer Center

Caro, Michigan, United States

Site Status RECRUITING

Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Site Status RECRUITING

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Site Status RECRUITING

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, United States

Site Status RECRUITING

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status RECRUITING

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status RECRUITING

Hurley Medical Center

Flint, Michigan, United States

Site Status RECRUITING

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status RECRUITING

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, United States

Site Status RECRUITING

Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, United States

Site Status RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States

Site Status RECRUITING

Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, United States

Site Status RECRUITING

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status RECRUITING

Hope Cancer Center

Pontiac, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

Site Status RECRUITING

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status RECRUITING

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status RECRUITING

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Site Status RECRUITING

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, United States

Site Status RECRUITING

Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, United States

Site Status RECRUITING

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status RECRUITING

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status RECRUITING

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status RECRUITING

Cambridge Medical Center

Cambridge, Minnesota, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status RECRUITING

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status RECRUITING

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status RECRUITING

Fairview Northland Medical Center

Princeton, Minnesota, United States

Site Status RECRUITING

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status RECRUITING

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status RECRUITING

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status RECRUITING

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status RECRUITING

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Site Status RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Great Falls Clinic

Great Falls, Montana, United States

Site Status RECRUITING

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Community Medical Center

Missoula, Montana, United States

Site Status RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Site Status RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status RECRUITING

Saint Elizabeth Boardman Hospital

Boardman, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status RECRUITING

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, United States

Site Status RECRUITING

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Site Status RECRUITING

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status RECRUITING

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status RECRUITING

Orion Cancer Care

Findlay, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC-Wayne

Greenville, Ohio, United States

Site Status RECRUITING

Wayne Hospital

Greenville, Ohio, United States

Site Status RECRUITING

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status RECRUITING

Kettering Medical Center

Kettering, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC - Troy

Troy, Ohio, United States

Site Status RECRUITING

Saint Joseph Warren Hospital

Warren, Ohio, United States

Site Status RECRUITING

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Baker City

Baker City, Oregon, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Site Status RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status RECRUITING

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status RECRUITING

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Site Status RECRUITING

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

Site Status RECRUITING

The West Clinic - Wolf River

Germantown, Tennessee, United States

Site Status RECRUITING

MD Anderson in The Woodlands

Conroe, Texas, United States

Site Status RECRUITING

Lyndon Baines Johnson General Hospital

Houston, Texas, United States

Site Status RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

MD Anderson West Houston

Houston, Texas, United States

Site Status RECRUITING

MD Anderson League City

League City, Texas, United States

Site Status RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status RECRUITING

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status RECRUITING

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2024-04336

Identifier Type: REGISTRY

Identifier Source: secondary_id

S2312

Identifier Type: OTHER

Identifier Source: secondary_id

S2312

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S2312

Identifier Type: -

Identifier Source: org_study_id