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Spots Global Cancer Trial Database for Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

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Trial Identification

Brief Title: Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

Official Title: Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer

Study ID: NCT05710406

Study Description

Brief Summary: This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.

Detailed Description: The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To evaluate and compare 6 month circulating tumor deoxyribonucleic acid (ctDNA) clearance rate in study patients with detectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase II) II. To evaluate and compare 6 month ctDNA recurrence-free survival (ctDNA-RFS) rate in study patients with undetectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase II) III. To evaluate and compare disease-free survival (DFS) (measured from randomization) in patients with resected stage III or high-risk (pT4) stage II mismatch repair protein (MMR) proficient BRAF V600E colon cancer treated with targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase III) SECONDARY OBJECTIVES: I. To evaluate and compare overall survival (OS) between the two treatment arms. II. To evaluate and compare the toxicity profile between the two treatment arms. III. To evaluate and compare the alternative DFS endpoint (measured from date of primary tumor resection) between the two treatment arms. IV. To evaluate and compare DFS in the subset of patients with detectable ctDNA prior to randomization between the two treatment arms. EXPLORATORY OBJECTIVE: I. To evaluate and compare patient-reported outcomes for symptoms of rash, diarrhea, and fatigue according to Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) between the two treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive encorafenib orally (PO) and cetuximab intravenously (IV) on study. Patients also undergo collection of blood samples throughout the study and computed tomography (CT) or magnetic resonance imaging (MRI) during screening and follow-up. ARM II: Patients undergo observation per usual care on study. Patients also undergo collection of blood samples throughout the study and CT or MRI during screening and follow-up.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beebe South Coastal Health Campus, Frankford, Delaware, United States

Helen F Graham Cancer Center, Newark, Delaware, United States

Medical Oncology Hematology Consultants PA, Newark, Delaware, United States

Beebe Health Campus, Rehoboth Beach, Delaware, United States

Emory University Hospital Midtown, Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States

Pali Momi Medical Center, 'Aiea, Hawaii, United States

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States

Queen's Medical Center, Honolulu, Hawaii, United States

Straub Clinic and Hospital, Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States

Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States

Kootenai Cancer Clinic, Sandpoint, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States

Illinois CancerCare-Bloomington, Bloomington, Illinois, United States

Illinois CancerCare-Canton, Canton, Illinois, United States

Illinois CancerCare-Carthage, Carthage, Illinois, United States

Northwestern University, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Carle at The Riverfront, Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States

Illinois CancerCare-Dixon, Dixon, Illinois, United States

Carle Physician Group-Effingham, Effingham, Illinois, United States

Crossroads Cancer Center, Effingham, Illinois, United States

Illinois CancerCare-Eureka, Eureka, Illinois, United States

Illinois CancerCare-Galesburg, Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States

Northwestern Medicine Glenview Outpatient Center, Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center, Grayslake, Illinois, United States

Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States

Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States

Illinois CancerCare-Macomb, Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States

Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States

Northwestern Medicine Orland Park, Orland Park, Illinois, United States

University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States

Illinois CancerCare-Pekin, Pekin, Illinois, United States

Illinois CancerCare-Peoria, Peoria, Illinois, United States

Illinois CancerCare-Peru, Peru, Illinois, United States

Illinois CancerCare-Princeton, Princeton, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Springfield Clinic, Springfield, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States

Illinois CancerCare - Washington, Washington, Illinois, United States

Northwest Cancer Center - Main Campus, Crown Point, Indiana, United States

Northwest Oncology LLC, Dyer, Indiana, United States

Northwest Cancer Center - Hobart, Hobart, Indiana, United States

Saint Mary Medical Center, Hobart, Indiana, United States

Saint Catherine Hospital, Indianapolis, Indiana, United States

The Community Hospital, Munster, Indiana, United States

Women's Diagnostic Center - Munster, Munster, Indiana, United States

Northwest Cancer Center - Valparaiso, Valparaiso, Indiana, United States

Mission Cancer and Blood - Ankeny, Ankeny, Iowa, United States

Mercy Hospital, Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States

Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States

Trinity Health Medical Center - Brighton, Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, United States

Trinity Health Medical Center - Canton, Canton, Michigan, United States

Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States

Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States

Genesee Hematology Oncology PC, Flint, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States

Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States

Huron Gastroenterology PC, Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States

Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Saint Francis Medical Center, Cape Girardeau, Missouri, United States

Community Hospital of Anaconda, Anaconda, Montana, United States

Billings Clinic Cancer Center, Billings, Montana, United States

Bozeman Health Deaconess Hospital, Bozeman, Montana, United States

Benefis Sletten Cancer Institute, Great Falls, Montana, United States

Community Medical Center, Missoula, Montana, United States

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Memorial Sloan Kettering Commack, Commack, New York, United States

Glens Falls Hospital, Glens Falls, New York, United States

Memorial Sloan Kettering Westchester, Harrison, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Upstate Cancer Center at Oswego, Oswego, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

SUNY Upstate Medical Center-Community Campus, Syracuse, New York, United States

Memorial Sloan Kettering Nassau, Uniondale, New York, United States

Upstate Cancer Center at Verona, Verona, New York, United States

Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

Sanford Bismarck Medical Center, Bismarck, North Dakota, United States

Sanford Broadway Medical Center, Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States

Aultman Health Foundation, Canton, Ohio, United States

Miami Valley Hospital South, Centerville, Ohio, United States

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Miami Valley Hospital, Dayton, Ohio, United States

Premier Blood and Cancer Center, Dayton, Ohio, United States

Miami Valley Hospital North, Dayton, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States

Miami Valley Cancer Care and Infusion, Greenville, Ohio, United States

Cleveland Clinic Cancer Center Independence, Independence, Ohio, United States

Cleveland Clinic Cancer Center Mansfield, Mansfield, Ohio, United States

Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States

North Coast Cancer Care, Sandusky, Ohio, United States

Cleveland Clinic Cancer Center Strongsville, Strongsville, Ohio, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States

Upper Valley Medical Center, Troy, Ohio, United States

South Pointe Hospital, Warrensville Heights, Ohio, United States

Cleveland Clinic Wooster Family Health and Surgery Center, Wooster, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Pocono Medical Center, East Stroudsburg, Pennsylvania, United States

Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States

Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States

Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States

Community Medical Center, Scranton, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States

Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States

Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States

Gibbs Cancer Center-Gaffney, Gaffney, South Carolina, United States

Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States

Gibbs Cancer Center-Pelham, Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States

Spartanburg Medical Center, Spartanburg, South Carolina, United States

MGC Hematology Oncology-Union, Union, South Carolina, United States

Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

Parkland Memorial Hospital, Dallas, Texas, United States

UT Southwestern Simmons Cancer Center - RedBird, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth, Texas, United States

UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States

Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States

Swedish Medical Center-First Hill, Seattle, Washington, United States

West Virginia University Charleston Division, Charleston, West Virginia, United States

Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States

ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States

ThedaCare Cancer Care - Berlin, Berlin, Wisconsin, United States

Aspirus Medford Hospital, Medford, Wisconsin, United States

ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States

ThedaCare Regional Medical Center - Neenah, Neenah, Wisconsin, United States

Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States

Ascension Saint Mary's Hospital, Rhinelander, Wisconsin, United States

ThedaCare Cancer Care - Shawano, Shawano, Wisconsin, United States

Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States

UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States

ThedaCare Cancer Care - Waupaca, Waupaca, Wisconsin, United States

Aspirus Regional Cancer Center, Wausau, Wisconsin, United States

Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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