{"preliminary_commentary":{"by_channel":{"x_thread":4},"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":"COBRA","nct_id":"NCT04068103","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=cobra-nct04068103. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients undergo active surveillance.","label":"Arm I (blood stored and tested for ctDNA later)","type":"ACTIVE_COMPARATOR"},{"description":"Patients are assigned to 1 of 2 groups.\n\nGROUP I (ctDNA DETECTED): At the discretion of the investigator, patients receive either oxaliplatin IV over 2 hours on day 1, leucovorin IV over 2 hours on day 1, and fluorouracil IV bolus over 2-4 minutes on day 1 and then by continuous IV over 46-48 hours repeated every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 1-14 repeated every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity at the discretion of the investigator.\n\nGROUP II (ctDNA NOT DETECTED): Patients undergo active surveillance.","label":"Arm II (blood tested for ctDNA at baseline)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2026-06-21","type":"ESTIMATED"},"conditions":["Colon Adenocarcinoma","Stage IIA Colon Cancer AJCC v8"],"enrollment":{"count":635,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Capecitabine","otherNames":["Ro 09-1978/000","Xeloda"],"type":"DRUG"},{"name":"Fluorouracil","otherNames":["5-Fluoro-2,4(1H, 3H)-pyrimidinedione","5-Fluorouracil","5-Fluracil","5-FU","AccuSite","Carac","Fluoro Uracil","Fluouracil","Flurablastin","Fluracedyl","Fluracil","Fluril","Fluroblastin","Ribofluor","Ro 2-9757","Ro-2-9757"],"type":"DRUG"},{"name":"Leucovorin","otherNames":["Folinic acid"],"type":"DRUG"},{"name":"Leucovorin Calcium","otherNames":["Adinepar","Calcifolin","Calcium (6S)-Folinate","Calcium Folinate","Calcium Leucovorin","Calfolex","Calinat","Cehafolin","Citofolin","Citrec","citrovorum factor","Cromatonbic Folinico","Dalisol","Disintox","Divical","Ecofol","Emovis","Factor, Citrovorum","Flynoken A","Folaren","Folaxin","FOLI-cell","Foliben","Folidan","Folidar","Folinac","Folinate Calcium","folinic acid","Folinic Acid Calcium Salt Pentahydrate","Folinoral","Folinvit","Foliplus","Folix","Imo","Lederfolat","Lederfolin","Leucosar","leucovorin","Rescufolin","Rescuvolin","Tonofolin","Wellcovorin"],"type":"DRUG"},{"name":"Oxaliplatin","otherNames":["1-OHP","Ai Heng","Aiheng","Dacotin","Dacplat","Diaminocyclohexane Oxalatoplatinum","Eloxatin","Eloxatine","JM-83","Oxalatoplatin","Oxalatoplatinum","RP 54780","RP-54780","SR-96669"],"type":"DRUG"},{"name":"Patient Observation","otherNames":["Active Surveillance","deferred therapy","expectant management","observation","Watchful Waiting"],"type":"OTHER"}],"last_update":"2025-05-07","lead_sponsor":"NRG Oncology","official_title":"Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2023-06-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the \"Baseline ctDNA Detected\" Patient Subset (Phase II)","timeFrame":"Baseline up to 6 months"},{"measure":"Recurrence-free Survival (RFS) the \"Baseline ctDNA Detected\" Patient Subset (Phase III)","timeFrame":"Time to recurrence or death, assessed up to 3 years"}],"references":[],"start_date":{"date":"2019-12-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery","url":"https://clinicaltrials.gov/study/NCT04068103"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/cobra-nct04068103"}