{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT03803553","nct_id":"NCT03803553","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03803553. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study . The participant will be randomized into 1 of 3 groups : ctDNA-Positive: Folfiri or ctDNA-Positive: Active Surveillance or ctDNA Negative: Active Surveillance\n\n\\- ctDNA-POSITIVE: FOLFIRI Protocol\n\n* FOLFIRI chemotherapy via intravenous infusion on days 1-3 of each cycle. Cycle is 14 days long. This will occur for up to 12 cycles (24 weeks).\n* infusions will consist of the drugs\n* 5-Fluorouracil\n* Irinotecan\n* Leucovorin","label":"ctDNA-POSITIVE: FOLFIRI Protocol","type":"EXPERIMENTAL"},{"description":"Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study . The participant will be randomized into 1 of 3 groups : ctDNA-Positive: Folfiri or ctDNA-Positive: Active Surveillance or ctDNA Negative: Active Surveillance\n\n\\-- Active surveillance.\n\n* Observation and monitoring with imaging (every 3 months), tumor markers, and ctDNA draws every 1 month for the initial 6 months.\n* After 6 months, followed with ctDNA, tumor markers, and scans every 3 months for the first 3 years and every 6 months thereafter.\n\nAdditional scans and tumor markers will be at the discretion of the clinician. .","label":"ctDNA-POSITIVE: ACTIVE SURVEILLANCE","type":"ACTIVE_COMPARATOR"},{"description":"Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study . The participant will be randomized into 1 of 3 groups : ctDNA-Positive: Folfiri or ctDNA-Positive: Active Surveillance or ctDNA Negative: Active Surveillance\n\n\\- Observation and monitoring with imaging, tumor markers, and ctDNA collections every 3 months for the first 3 years and every 6 months thereafter.\n\nAdditional scans and tumor markers will be at the discretion of the clinician","label":"ctDNA-NEGATIVE: ACTIVE SURVEILLANCE","type":"ACTIVE_COMPARATOR"},{"description":"Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests.\n\nIf these tests show that the participant is eligible to participate in the research study and is ctDNA positive and MSI-H, the participant will not be randomized and will be placed into the group: ctDNA positive, MSI-H: Nivolumab\n\n-ctDNA-Positive, MSI-H: Nivolumab Protocol\n\n* Nivolumab treatment via intravenous infusion on day 1 of each cycle. Cycle is 28 days long. This will occur for up to 12 cycles (48 weeks).\n* infusions will consist of the drug Nivolumab","label":"ctDNA-POSITIVE MSI-H: NIVOLUMAB","type":"EXPERIMENTAL"},{"description":"Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests.\n\nIf these tests show that the participant is eligible to participate in the research study and is ctDNA positive and has a BRAF mutation, the participant will not be randomized and will be placed into the group: ctDNA positive, BRAF mutant: Encorafenib/Binimetinib/Cetuximab\n\n-ctDNA-Positive, MSI-H: Encorafenib/Binimetinib/Cetuximab Protocol\n\n* Encorafenib/Binimetinib treatment is received orally every day and Cetuximab via intravenous infusion on day 1 of each cycle. Cycle is 14 days long. This will occur for up to 12 cycles (24 weeks).\n* infusions will consist of the drug Cetuximab","label":"ctDNA-POSITIVE BRAF Mutant: ENCORAFENIB/BINIMETINIB/CETUXIMAB","type":"EXPERIMENTAL"},{"description":"Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. Participants that are eligible to receive Trastuzumab and Pertuzumab will be placed in this HER2 cohort: ctDNA-positive \\& HER2 amplification and MSS Trastuzumab and Pertuzumab. Trastuzumab is received via intravenous administration, and Pertuzumab treatment is received intravenously by infusion. Cycle is 21 days. This will occur for up to 8 cycles.","label":"6 Months Additional Trastuzumab and Pertuzumab","type":"EXPERIMENTAL"}],"collaborators":["Stand Up To Cancer"],"completion_date":{"date":"2027-12","type":"ESTIMATED"},"conditions":["Metastatic Colon Cancer","Stage III Colon Cancer"],"enrollment":{"count":400,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"FOLFIRI Protocol","otherNames":["FOLinic acid-Fluorouracil-IRInotecan regimen"],"type":"DRUG"},{"name":"ACTIVE SURVEILLANCE","otherNames":[],"type":"OTHER"},{"name":"Nivolumab Protocol","otherNames":["Nivolumab"],"type":"DRUG"},{"name":"Encorafenib/Binimetinib/Cetuximab Protocol","otherNames":["Enco/Bini/Cetux"],"type":"DRUG"},{"name":"Trastuzumab + Pertuzumab","otherNames":["Herceptin"],"type":"DRUG"}],"last_update":"2026-09-09","lead_sponsor":"Massachusetts General Hospital","official_title":"Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Disease-free survival (DFS)","timeFrame":"5 years"},{"measure":"Clearance rate of ctDNA","timeFrame":"7 Months"}],"references":[],"start_date":{"date":"2020-04-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer","url":"https://clinicaltrials.gov/study/NCT03803553"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03803553"}