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Alkylating agent

Irinotecan + FOLFOX Chemotherapy for Rectal Cancer (JANUS Trial)

Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial compares effects of two chemo drugs to treat rectal cancer after radiation therapy. Results may help avoid surgery for some patients.

Who is the study for?
This trial is for adults with stage II-III rectal cancer, located within 12cm of the anal verge, who haven't had chemotherapy or radiation for colorectal cancer in the last 5 years. They must be healthy enough to participate (ECOG <=2), not pregnant or nursing, and willing to use effective contraception. People with certain heart conditions, HIV on effective treatment, and those not on strong CYP3A4 inhibitors/inducers are eligible.Check my eligibility
What is being tested?
The study tests if adding Irinotecan to standard FOLFOX chemotherapy after long-course radiation improves complete response rates and organ preservation in advanced-stage rectal cancer patients compared to using FOLFOX alone.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, fatigue, hair loss from Irinotecan; nerve damage (neuropathy), allergic reactions from Oxaliplatin; mouth sores and low blood counts from both chemotherapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clincal Complete Response (cCR) Rates
Secondary outcome measures
Disease-free survival (DFS) rate
Incidence of adverse events (AEs)
Organ-preservation-time (OPT)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (LCRT, FOLFIRINOX)Experimental Treatment10 Interventions
Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.
Group II: Group I (LCRT, FOLFOX or CAPOX)Active Control9 Interventions
Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin IV, fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine PO, and oxaliplatin IV on study. Patients undergo CT scan, MRI, and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
biopsy
2002
Completed Phase 4
~8270
Computed Tomography
2017
Completed Phase 2
~2720
Sigmoidoscopy
2007
Completed Phase 2
~140
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Capecitabine
2013
Completed Phase 3
~3420
5-fluorouracil
2005
Completed Phase 4
~7960
Leucovorin calcium
2014
Completed Phase 3
~3620
Irinotecan
2017
Completed Phase 4
~2680
Oxaliplatin
2011
Completed Phase 4
~2560

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for rectal cancer, such as FOLFOX (fluorouracil, leucovorin, oxaliplatin) and CAPOX (capecitabine, oxaliplatin), work through various mechanisms to inhibit tumor growth. Fluorouracil and capecitabine are antimetabolites that interfere with DNA synthesis, preventing cancer cells from dividing. Oxaliplatin is a platinum-based drug that causes DNA crosslinking, leading to cell death. Irinotecan, a topoisomerase I inhibitor, prevents DNA unwinding, which is crucial for replication and transcription. These mechanisms are vital for rectal cancer patients as they target different aspects of cancer cell proliferation, increasing the likelihood of treatment success and potentially improving outcomes.

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,314 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,089 Total Patients Enrolled
J. Joshua Smith, MDStudy ChairMemorial Sloan Kettering Cancer Center

Media Library

Oxaliplatin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT05610163 — Phase 2
Rectal Cancer Research Study Groups: Group I (LCRT, FOLFOX or CAPOX), Group II (LCRT, FOLFIRINOX)
Rectal Cancer Clinical Trial 2023: Oxaliplatin Highlights & Side Effects. Trial Name: NCT05610163 — Phase 2
Oxaliplatin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610163 — Phase 2
~16 spots leftby Sep 2024