Anal Canal Cancer. Clinical Trial
Official title:
A Phase II Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.
The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which
corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been
growing recently. The standard treatment of anal cancer stage II-III is multimodal and
consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and
radiotherapy. This scheme currently used was proposed in 1974, and since then no other
effective treatment has been developed.
The purpose of this study is to determine the efficacy and toxicity of the combination of
capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal.
For this will be selected 51 patients to be treated with chemo-radiotherapy.
The primary endpoint will be local control rate after 6 months of the end of radiotherapy
and chemotherapy, defined by the rate of radiological and clinical neoplasia.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment