{"entity":{"id":"nct04495088","kind":"trial","name":"Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), cAPOX (capecitabine, oxaliplatin) and capecitabine in colorectal cancer, run by Ralf Hofheinz, now recruiting.","summary":"Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT04495088 by Ralf Hofheinz, with a registry enrolment figure of 550 participants, started 2020-09-30 and due to reach its primary completion in 2030-08. Interventions recorded: mFOLFOX (neoadjuvant); XELOX (neoadjuvant); mFOLFOX (adjuvant); XELOX (adjuvant); Capecitabine (adjuvant); infusional 5-FU/FA \"AIO\" regimen (adjuvant); infusional 5-FU/FA \"de Gramont\" (adjuvant). Conditions listed: Rectal Cancer. Primary outcome: disease-free survival. Colorectal eligibility wording from the registry: \"Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measured by rigid rectoscopy (i\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04495088","url":"https://clinicaltrials.gov/study/NCT04495088"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04495088","phase":"3","setting":"Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer and Low Risk for Local Failure: A Randomized Phase III Trial of the German Rectal Cancer Study Group","sponsor":"Ralf Hofheinz","enrolled":550,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04495088/","neighbours":{"cancer":[{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}