General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT05610163

Background Information

This study is being done to answer the following question:

Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation for patients with locally advanced rectal cancer?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive 
Fairfax, VA 22031
Principal Investigator

Jasmine Huynh, MD

Eligibility Information

  • Clinical stage II or III rectal adenocarcinoma defined as T4N0, or any T with node positive disease (any T, N+); also T3N0 requiring APR or coloanal anastomosis
  • Age ≥ 18 years
  • ECOG Performance Status 0-1

Ineligibility Information

  • Prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years
  • Upper rectal tumors
  • Recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
  • Known mismatch repair deficient rectal adenocarcinoma