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, MD
Status
Closed to Accrual
Date Opened To Accrual
November 09 2022
Date Closed to Accrual
July 21 2025
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.