Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer (NCT03803553) | Clinical Trial Compass
RecruitingPhase 3
Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer
United States400 participantsStarted 2020-04-16
Plain-language summary
This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colon cancer.
The names of the potential treatments involved in this study are:
* Active surveillance
* FOLFIRI treatment
* Nivolumab treatment
* Encorafenib/Binimetinib/Cetuximab treatment
* Trastuzumab + Pertuzumab
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically confirmed resected Stage III adenocarcinoma of the colon. Any T \[Tx, T1, T2, T3, or T4-\], N1-2M0.
* Participants must have completely resected disease. In patients with tumor adherent to adjacent structures, en block RO resection must be documented.
* Entire tumor must be in the colon (rectal involvement is excluded).
* Participants must have completed standard adjuvant chemotherapy per the discretion of the treating physician. Standard therapy includes FOLFOX, CAPOX, or therapy with 5FU analog alone will be permitted if it constitutes appropriate standard therapy in the opinion of the treating physician.
* Participants must not have received prior neoadjuvant chemotherapy.
* Age ≥18 years.
* ECOG performance status ≤1.
* Life expectancy of greater than 3 months.
* Participants must have normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/ mcL
* total bilirubin within normal institutional limits. For patients with Gilbert's syndrome, total bilirubin must be ≤ 2 and documented as elevated indirect bilirubin.
* AST(SGOT)/ALT(SGPT) ≤3 (AST) or ≤ 3 (ALT) × institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional normal by Cockroft-Gault formula.
* In order to be eligible for the ctDNA positiv…