# Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage

Source: https://onco.cc/trials/nct05610163/  
OnCo record `nct05610163` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: JANUS
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT05610163: https://clinicaltrials.gov/study/NCT05610163

## Connected records

- cancers: [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [Platinum agents](https://onco.cc/technologies/platinum/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [FOLFIRI (5-FU, leucovorin, irinotecan)](https://onco.cc/drugs/folfiri/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/)
- companies: [Alliance for Clinical Trials in Oncology](https://onco.cc/companies/alliance-oncology/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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