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 (NCT05610163)
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
🩺 Plain-English Summary (8th-Grade Level)
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (685 Sites)
Showing the first 25 of 685 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska
- Alaska Oncology and Hematology LLC — Anchorage, Alaska
- Alaska Women's Cancer Care — Anchorage, Alaska
- Anchorage Oncology Centre — Anchorage, Alaska
- Katmai Oncology Group — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- Kingman Regional Medical Center — Kingman, Arizona
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
- PCR Oncology — Arroyo Grande, California
- Keck Medicine of USC Buena Park — Buena Park, California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
- Mercy Cancer Center - Carmichael — Carmichael, California
- Mercy San Juan Medical Center — Carmichael, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Mercy Cancer Center - Elk Grove — Elk Grove, California
- Washington Hospital — Fremont, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Locally Advanced Rectal Carcinoma
Explore by condition: All Locally Advanced Rectal Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.