Clinical Trial TitleEA2182: A Randomized Phase II Study De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)
National Clinical Trial Number:NCT04166318
Clinical Trial Protocol Description:
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy X-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically proven T1-2N0M0 invasive anal cancer or anal margin squamous cell carcinoma with tumors measuring =< 4cm.
- Have no history or prior radiation or chemotherapy for this malignancy.
- Have Not had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus.
- Are not receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.