Trials in Progress Update: The Janus Rectal Cancer Trial (Alliance A022104/NRG-GI010)

March 12 2024

The Janus Rectal Cancer Trial (Alliance A022104/NRG-GI010): 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

Opened to enrollment in November 2022, the Janus Rectal Cancer trial is comparing the effect of FOLFIRINOX versus FOLFOX systemic chemotherapy after long-course chemoradiation in patients with locally advanced rectal cancer. The goal is to determine if the clinical complete response (cCR) rate will increase for this patient population by adding irinotecan to the standard regimen of chemotherapy following long-course chemoradiation (LCCRT).

In an attempt to maximize the potential to achieve a cCR and provide an opportunity for a watch and wait treatment deferring surgery, this study hypothesizes that mFOLFIRINOX (leucovorin, 5-fluorouracil, irinotecan, oxaliplatin) after chemoradiation may increase the response rate and lead to a higher cCR rate compared to FOLFOX or CAPOX after LCCRT in patients with locally advanced rectal cancer.

Trial participants will be randomized into two groups. Group 1 will receive the usual drug combination of FOLFOX or CAPOX after LCCRT and Group 2 will receive FOLFIRINOX after LCCRT. Each group will enroll about 156 participants (current total enrollment is 241). This phase II study is under discussion with NCI to expand to a definitive phase III study design with expanded opportunities for patient enrollments.

The Janus trial is important for our rectal cancer patients as we aim to improve their chances to avoid surgery after a complete response and improve long-term organ preservation rates. Preserving the rectum may offer a significant quality of life benefit for those patients who achieve a cCR.

More information about The Janus Trial can be found on clinical

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