A Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Anal Canal Cancer.

Intervention / Treatment
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* Drug: Capecitabine
* Drug: Mitomycins
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive anal canal SCC histologically confirmed, T2-4 N0 M0, T (anyone) N1-3 M0 - according to TNM staging system. Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. Adequate medullar function, defined as: Absolute neutrophil count ≥ 1,5×109/L; platelets ≥100×109/L; hemoglobin ≥10g/dl. Serum AST (aspartato aminotransferase) and ALT (alanine aminotransferase) < 3 × ULN (upper limit of normal). Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min. Signed written informed consent. Exclusion Criteria: Major surgical procedure within 4 weeks of the beginning of the treatment. History of severe systemic or psychiatric disease. Previous treatment for anal canal carcinoma or other cancer. For female patients, current pregnancy and/or lactation Unstable angina or acute myocardial infarction within 6 months. Concomitant use of oral anticoagulants HIV positive with result of CD4 ≤ 200. Previously pelvic radiotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemo-radiotherapy<br>Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy | Drug: Capecitabine<br>* 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.<br>Drug: Mitomycins<br>* 15 mg/m2, IV, bolus, single dose on day 1 of radiotherapy<br>Radiation: Radiotherapy<br>* Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months of the end of radiotherapy and chemotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Toxicity | Adverse events grade 3 and 4 according to CTCAE 3.0 (Common Toxicity Criteria for Adverse Effects). | 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. | 4 weeks after the end of the treatment | 
| Overall survival |  | 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 |  | 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 |  | Within 1 year after the end of the treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal canal cancer;capecitabine; mitomycin; radiotherapy.