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

This study is being done to answer the following question: Is using a lower-dose regimen of chemoradiation therapy as effective and does it have fewer side effects, compared to the standard-dose regimen of chemoradiation therapy for patients with anal 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 anal cancer. There is not an established treatment that is individualized for patients with early-stage anal cancer. However, the usual approach is defined as care most people get for anal cancer.

Are you Eligible? (Inclusion Criteria)

• Be greater than or equal to 18 years of age
• Have histologically proven T1-2N0M0 invasive anal canal or anal margin squamous cell carcinoma with tumors measuring greater than or equal to 4cm within the last 4 weeks.
• Not have lymph node involvement
• Not have prior radiation or chemotherapy for this cancer