A Phase II Study Assessing the Addition of Irinotecan to Combination Chemotherapy after Chemoradiation in Patients with Stage II or III Rectal Cancer to Improve the Rate of Complete Response


Full 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 (CIRB)


Combinations of chemotherapy drugs such as FOLFIRINOX (irinotecan, fluorouracil, leucovorin, and oxaliplatin), FOLFOX (fluorouracil, leucovorin, and oxaliplatin), and CAPOX (capecitabine and oxaliplatin) work in different ways to hinder the growth of rectal cancer. FOLFOX or CAPOX after chemoradiation (chemotherapy plus radiation therapy) is the usual treatment for locally advanced rectal cancer.

In this study, researchers want to see if giving FOLFIRINOX after chemoradiation is more effective than FOLFOX or CAPOX after chemoradiation for improving the rate of complete response in patients with stage II or III rectal cancer. Participants will be randomly assigned to either:

  • Group 1: Chemoradiation followed by FOLFOX or CAPOX
  • Group 2: Chemoradiation followed by FOLFIRINOX

Capecitabine is taken orally and the other medications are given intravenously. Patients will be assessed at the end of treatment. If a complete response is achieved, they will then have the option of a “watch-and-wait” approach (which preserves the rectum) or radical surgery (total mesorectal excision). 

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have locally advanced (stage II or III) rectal cancer that has not yet been treated.
  • Patients’ tumors must be mismatch repair proficient (no loss of mismatch repair proteins).
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. J. Joshua Smith at 212-639-5807.




Phase II/III (phases 2 and 3 combined)



ClinicalTrials.gov ID