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.
- Conditions
- Anal Canal Cancer.
- Interventions
- Registration Number
- NCT01941966
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemo-radiotherapy Capecitabine Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy Chemo-radiotherapy Mitomycins Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy Chemo-radiotherapy Radiotherapy Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
- Primary Outcome Measures
Name Time Method 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
Name Time Method Treatment Toxicity Weekly during the treatment and ultil 28 days after the last dose of capecitabine or ultil the resolution of all adverse events. Adverse events grade 3 and 4 according to CTCAE 3.0 (Common Toxicity Criteria for Adverse Effects).
Complete Response 4 weeks after the end of the treatment Complete response rate 4 weeks after completion of chemotherapy and radiation therapy.
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. 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.
Trial Locations
- Locations (1)
ICESP
🇧🇷Sao Paulo, SP, Brazil