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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

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 objective(s) 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 Exploratory objective Evaluation of ctDNA kinetics during neoadjuvant therapy & surveillance and to correlate with radiographic, pathologic, and clinical outcomes

Phase

II

Recruitment Status

Current Studies