Irinotecan + FOLFOX Chemotherapy for Rectal Cancer
(JANUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing different treatments in patients with advanced rectal cancer to see which one is more effective at shrinking the tumor or stopping its growth, potentially avoiding surgery.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A4 inhibitors or inducers (types of drugs that affect how your body processes other medications) at least 14 days before starting the study treatment.
Is the combination of Irinotecan and Oxaliplatin safe for humans?
The combination of Irinotecan and Oxaliplatin, used in chemotherapy for colorectal cancer, has been associated with various side effects such as myelosuppression (reduced bone marrow activity), diarrhea, nausea, and neurotoxicity (nerve damage). While these drugs can be effective, they may cause significant toxicity, and managing these side effects is important for patient safety.12345
How is the drug Irinotecan + FOLFOX different for rectal cancer treatment?
The combination of Irinotecan and FOLFOX, which includes oxaliplatin, is unique because it combines multiple chemotherapy agents that work together to improve outcomes in colorectal cancer, especially when other treatments have failed. This regimen is notable for its synergistic effects and non-overlapping side effects, potentially offering better response rates compared to standard treatments.678910
What data supports the effectiveness of the drug combination Irinotecan and Oxaliplatin for rectal cancer?
Research shows that the combination of Irinotecan and Oxaliplatin is effective in treating advanced colorectal cancer, which is similar to rectal cancer. Studies have found that these drugs work well together and can be used as a first-line treatment, meaning they are often the first choice for treating this type of cancer.1011121314
Who Is on the Research Team?
J. Joshua Smith, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive long-course chemoradiation therapy
Chemotherapy
Participants receive either FOLFOX or CAPOX regimen in Group I, or FOLFIRINOX regimen in Group II
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Irinotecan
- Oxaliplatin
Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator