Rectal Cancer - Janus

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

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.

Criteria:

  • 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
  • Not pregnant and not nursing
  • Age ≥ 18 years
  • ECOG Performance Status 0-1
  • 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

Locations: Hartford Hospital, Hospital of Central Connecticut, Midstate Medical Center
Sponsor: Alliance
Contact: Siobhan Reilly, [email protected]

Cancer Clinical Research Office