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Combining Irinotecan with Standard Chemotherapy for Advanced Rectal Cancer

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

Phase 2 Interventional Alliance for Clinical Trials in Oncology · NCT05610163

This study is testing whether adding irinotecan to standard chemotherapy after radiation can help people with advanced rectal cancer respond better to treatment and keep their organs.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment312 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations662 sites (Birmingham, Alabama and 661 other locations)
Trial IDNCT05610163 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of adding irinotecan to the standard chemotherapy regimen (FOLFOX) following long-course radiation therapy in patients with locally advanced rectal cancer. The study aims to compare the rates of clinical complete response (cCR) and organ preservation between two treatment groups: one receiving modified FOLFIRINOX and the other receiving modified FOLFOX6 after chemoradiation. Secondary objectives include evaluating disease-free survival, overall survival, and toxicity profiles. Patients will be randomized to receive either treatment after undergoing neoadjuvant long-course radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are individuals with clinical stage II or III rectal adenocarcinoma who have not received prior systemic chemotherapy or radiation therapy for colorectal cancer.

Not a fit: Patients with rectal cancer who have previously undergone systemic chemotherapy or radiation therapy within the past five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the rate of complete response and increase the chances of organ preservation in patients with advanced rectal cancer.

How similar studies have performed: Other studies have shown promising results with similar combination chemotherapy approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
* Tumor site: Rectum; =\< 12cm from the anal verge
* No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

  \* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =\< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for \>= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for \>= 6 months after the last treatment
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm
* Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min

  \^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
* No upper rectal tumors (distal margin of tumor \> 12 cm from the anal verge)
* No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
* No known mismatch repair deficient rectal adenocarcinoma
* Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study \* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Where this trial is running

Birmingham, Alabama and 661 other locations

+612 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced Rectal CarcinomaStage II Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.