Active Not Recruiting PHASE2 INTERVENTIONAL 2-arm NCT05610163

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 (JANUS)

The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

Sponsor: Alliance for Clinical Trials in Oncology

Conditions Locally Advanced Rectal Carcinoma Stage II Rectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8

Interventions 5-fluorouracil Capecitabine Computed Tomography Irinotecan Leucovorin calcium Long Course Chemoradiotherapy Magnetic Resonance Imaging Oxaliplatin Sigmoidoscopy biopsy

Updated 19 times since 2022 Last updated: Sep 5, 2025 Started: Dec 8, 2022 Primary completion: Sep 30, 2026 Completion: Sep 30, 2033

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Locally Advanced Rectal Carcinoma and Stage II Rectal Cancer AJCC v8, this trial is ongoing. The trial is conducted by Alliance for Clinical Trials in Oncology and has accumulated 19 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

19 versions recorded

Oct 2025 — Present [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE2
Jul 2025 — Sep 2025 [monthly]

Recruiting PHASE2
May 2025 — Jul 2025 [monthly]

Recruiting PHASE2
Feb 2025 — May 2025 [monthly]

Recruiting PHASE2

▶ Show 14 earlier versions

Jan 2025 — Feb 2025 [monthly]

Recruiting PHASE2
Nov 2024 — Jan 2025 [monthly]

Recruiting PHASE2
Sep 2024 — Nov 2024 [monthly]

Recruiting PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE2
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE2
May 2024 — Jun 2024 [monthly]

Recruiting PHASE2
Mar 2024 — May 2024 [monthly]

Recruiting PHASE2
Dec 2023 — Mar 2024 [monthly]

Recruiting PHASE2
Sep 2023 — Dec 2023 [monthly]

Recruiting PHASE2
Aug 2023 — Sep 2023 [monthly]

Recruiting PHASE2
Jun 2023 — Aug 2023 [monthly]

Recruiting PHASE2
Apr 2023 — Jun 2023 [monthly]

Recruiting PHASE2
Feb 2023 — Apr 2023 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
Dec 2022 — Feb 2023 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Data source: Alliance for Clinical Trials in Oncology

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aberdeen, United States , Albemarle, United States , Albuquerque, United States , Allentown, United States , Altamonte Springs, United States , Alton, United States , Altoona, United States , Amarillo, United States , Anchorage, United States , Anderson, United States and 451 more locations