A021502 Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: III
Principal Investigator: Klute, Kelsey
Contact Information:
Brandie Booker, RN
402-559-8197
brandie.booker@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02912559#eligibility
Summary
PRIMARY OBJECTIVES:
I. To determine whether atezolizumab combined with oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX) and its continuation as monotherapy can significantly improve disease-free survival (DFS) compared to FOLFOX alone in patients with stage III colon cancers and deficient DNA mismatch repair (dMMR).
SECONDARY OBJECTIVES:
I. To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve overall survival compared to FOLFOX alone in patients with stage III colon cancers and dMMR.
II. To assess the adverse events (AE) profile and safety of each treatment arm, using the Common Terminology Criteria for Adverse Events (CTCAE) and patient related outcomes (PRO)-CTCAE.