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
Objective
Primary Objective: To evaluate and compare the cCR rates in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6.
Secondary Objectives: To evaluate and compare organ-preservation-time (OPT) between two treatment arms. To evaluate and compare the disease-free survival (DFS) time between the two treatment arms. To evaluate and compare time to distant metastasis between two treatment arms. To evaluate and compare overall survival (OS) between two treatment arms. To evaluate and compare toxicity profiles of TNT between two treatment arms
