{"entity":{"id":"nct05610163","kind":"trial","name":"Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage","aka":["JANUS"],"tldr":"A phase 2/3 trial of capecitabine, fluorouracil (5-FU), leucovorin (folinic acid), fOLFIRI (5-FU, leucovorin, irinotecan) and other drugs in colorectal cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response is a phase 2/3, randomised interventional study registered as NCT05610163 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 760 participants, started 2022-12-08 and due to reach its primary completion in 2026-09-30. Interventions recorded: Capecitabine; 5-fluorouracil; Leucovorin calcium; Irinotecan; Oxaliplatin; Long Course Chemoradiotherapy; Computed Tomography; Magnetic Resonance Imaging; Sigmoidoscopy; biopsy. Conditions listed: Stage II Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Locally Advanced Rectal Adenocarcinoma. Primary outcome: Clincal Complete Response (cCR) Rates (Phase II); Disease-free survival (DFS) rate (Phase III). Colorectal eligibility wording from the registry: \"* Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)\". Sites: Puerto Rico, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05610163","url":"https://clinicaltrials.gov/study/NCT05610163"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["capecitabine","fluorouracil","leucovorin","folfiri","folfox"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05610163","phase":"2/3","setting":"The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-free Survival in Patients With Locally Advanced Rectal Cancer","sponsor":"Alliance for Clinical Trials in Oncology","enrolled":760,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05610163/","neighbours":{"cancer":[{"id":"msi-high-colorectal","kind":"cancer","name":"Mismatch-repair deficient (MSI-high) colorectal cancer","route":"/cancers/msi-high-colorectal/"},{"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":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"folfiri","kind":"drug","name":"FOLFIRI (5-FU, leucovorin, irinotecan)","route":"/drugs/folfiri/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"}],"company":[{"id":"alliance-oncology","kind":"company","name":"Alliance for Clinical Trials in Oncology","route":"/companies/alliance-oncology/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}