A022104 NRG-GI010

Alliance/NRG Joint Study: 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 (The JANUS Rectal Cancer Trial)

Principal Investigator

William Hall

Status

Disease Site

Gastrointestinal [GI] Colorectal

Phase

II/III

Developmental Therapeutics

No

Primary Objective

Phase II: 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/CAPOX.

Phase III: To evaluate and compare disease-free survival (DFS) in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6/CAPOX

Alliance Study Chair: J. Joshua Smith, MD, PhD

NRG Study Champion: William Hall, MD

Patient Population

Patients with locally advanced rectal cancer.

Target Accrual

364