Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial
- Conditions
- Stage III Rectal Cancer AJCC v8Stage IIIC Colon Cancer AJCC v8Stage IVA Colon Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IVA Rectal Cancer AJCC v8Unresectable Rectal AdenocarcinomaStage IIIA Rectal Cancer AJCC v8Stage IIIB Colon Cancer AJCC v8Stage IV Colon Cancer AJCC v8Stage IV Rectal Cancer AJCC v8
- Interventions
- Other: Genetic Testing
- Registration Number
- NCT03765736
- Lead Sponsor
- Academic and Community Cancer Research United
- Brief Summary
This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.
- Detailed Description
PRIMARY OBJECTIVES:
I. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.
II. To facilitate clinically annotated genomic analyses.
OUTLINE:
Patients submit blood samples for genetic testing.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 199
-
Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
-
Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)
-
For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)
- Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
-
At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
-
Life expectancy >= 3 months per estimation of investigator
-
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
-
Capable of understanding and complying with the protocol requirements and has signed the informed consent document
-
Satisfy at least one of the following two conditions:
- Willing and able to provide blood sample for screening purposes
- Guardant 360 testing completed =< 60 days prior to registration
- Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of < 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
- Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
- History of solid organ transplantation
- Pregnant or planning to become pregnant within the next 12 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Screening (genetic testing) Genetic Testing Patients submit blood samples for genetic testing.
- Primary Outcome Measures
Name Time Method The Proportion of Patients Who Have an Actionable Genomic Profile 6 months This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
Companion Trial Enrollment 3.5 years This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Emory University Hospital/Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
USC / Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Aurora Cancer Care-Milwaukee
🇺🇸Milwaukee, Wisconsin, United States