Anal Canal Cancer.
Conditions
Keywords
Anal canal cancer;capecitabine; mitomycin; radiotherapy.
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.
Interventions
DRUGCapecitabine
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.
DRUGMitomycins
15 mg/m2, IV, bolus, single dose on day 1 of radiotherapy
RADIATIONRadiotherapy
Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. | — |
Countries
Brazil
Outcome results
None listed