Alliance A022104

Clinical Trial Title The Janus Rectal Cancer Trial: A randomized phase II/III trial testing the efficacy of triplet versus doublet chemotherapy regarding clinical complete response and disease-free survival in patients with locally advanced rectal cancer
Trial Status Open to Enrollment
Start Date 07/22/2024
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Rectal cancer
Description 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.
Eligibility Criteria

Eligibility Criteria

  • Histologic documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)
  • Clinical stage II or III rectal adenocarcinoma defined as T4N0, or any T with node positive disease (any T, N+); also T3N0 requiring APR or coloanal anastomosis
  • No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years
  • No upper rectal tumors (distal margin/edge of tumor > 12 cm from the anal verge)
  • Comorbid conditions: No recurrent rectal cancer; prior transanal excision, prior endoscopic submucosal dissection, prior distal sigmoid cancer with a low anastomosis

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | 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 | ClinicalTrials.gov
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org