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Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

Testing a new drug with chemotherapy for advanced rectal cancer.

Recruiting
18 years and older
All
Phase 2

This study involves testing if adding a cancer drug called irinotecan to a chemotherapy mix called FOLFOX, after a type of radiation therapy, can help treat advanced-stage rectal cancer better. FOLFOX is a standard treatment made up of drugs like fluorouracil, leucovorin, and oxaliplatin. This study compares FOLFOX with a different mix called FOLFIRINOX, which also includes irinotecan. These drugs aim to stop cancer cells from growing or spreading. In this trial, participants will receive one of two treatment plans after radiation: FOLFOX or FOLFIRINOX. They will undergo regular scans and tests, including CT and MRI scans, as well as biopsies. The goal is to see if the FOLFIRINOX treatment improves cancer response and helps preserve organs better than FOLFOX.

  • Participants must be at least 18 years old and have specific types of rectal cancer.
  • The study involves multiple visits for treatments and tests.
  • Women of childbearing age must use effective birth control during the study.
Study details
    Locally Advanced Rectal Carcinoma
    Stage II Rectal Cancer AJCC v8
    Stage III Rectal Cancer AJCC v8

NCT05610163

Alliance for Clinical Trials in Oncology

6 April 2025

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