A Phase 3 Study of Presurgical Chemotherapy, Surgery, and Observation Versus Chemoradiotherapy For Early Rectal Cancer

Full Title

The NEO-RT Trial: A Phase 3 Randomized Trial of Neoadjuvant Chemotherapy, Excision and Observation versus Chemoradiotherapy for Early Rectal Cancer (CCTG-CO32) (CIRB)

Purpose

A standard approach for early-stage rectal cancer is treatment with chemotherapy and radiation therapy followed by surgery. In this study, researchers are comparing two approaches to prevent the need for rectal resection (removal of all or nearly all of the rectum) in people with early rectal cancer: chemotherapy or chemotherapy and radiation with observation or limited surgery (removing only the area with the tumor, not the entire rectum).

If you take part in this study, you will be randomly assigned to get one of these treatments:

  • Chemotherapy followed by surgery
  • Chemotherapy with radiation therapy, followed by surgery

You will continue to be monitored periodically after surgery by the study doctor for up to 5 years.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have newly diagnosed early-stage rectal cancer that has not yet been treated.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Martin Weiser’s office at 212-639-7592.

Protocol

25-319

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06205485