A Phase II Study Evaluating the Effectiveness of a Lower Dose of Chemoradiation to Treat Early-Stage Anal Cancer

Share
Print

Full Title

A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE) (EA2182) (CIRB)

Purpose

A combination of chemotherapy and radiation therapy (“chemoradiation”) is a standard treatment for early-stage anal cancer. However, this treatment can cause side effects such as loose stools, skin irritation, and fatigue. In this study, researchers want to see if a less intense chemoradiation treatment plan is as effective as the standard approach but causes fewer side effects.

Patients will be randomly assigned to one of two groups. Both groups will receive the chemotherapy drugs mitomycin-C, 5-fluorouracil, and capecitabine plus radiation therapy. One group will receive the standard dose of chemoradiation and the other group will receive the lower dose. Capecitabine is taken orally (by mouth) and the other two medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage I-II anal cancer that has not yet been treated with surgery, chemotherapy, or radiation therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Romesser at 646-888-2118.

Protocol

20-118

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators