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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Capecitabine, PO, 825mg/m2, on days: 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15, 16, 17, 18, 19, 22, 23, 24, 25, 26, 29, 30, 31, 32, 33, 36, 37, 38, 39 and 40 of radiotherapy period.
15 mg/m2, IV, bolus, single dose on day 1 of radiotherapy
Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks
ICESP
São Paulo, São Paulo, Brazil
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.
Time frame: 6 months of the end of radiotherapy and chemotherapy.
Treatment Toxicity
Adverse events grade 3 and 4 according to CTCAE 3.0 (Common Toxicity Criteria for Adverse Effects).
Time frame: Weekly during the treatment and ultil 28 days after the last dose of capecitabine or ultil the resolution of all adverse events.
Complete Response
Complete response rate 4 weeks after completion of chemotherapy and radiation therapy.
Time frame: 4 weeks after the end of the treatment
Overall survival
Time frame: Every 3 months during the first year after the end of the treatment, then every 6 months in the second and third year, and after the fourth year the visit will be annual.
Progression-free survival
Time frame: A chest x-ray and computerized tomography of abdomen and pelviswill be performed after 6 weeks of the end of treatment and 6 months after.
Colostomy rate
Time frame: Within 1 year after the end of the treatment.
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