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.
| Verified date | March 2014 |
| Source | Instituto do Cancer do Estado de São Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | ICESP | Sao Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto do Cancer do Estado de São Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No | |
| Secondary | 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. | Yes |
| Secondary | Complete Response | Complete response rate 4 weeks after completion of chemotherapy and radiation therapy. | 4 weeks after the end of the treatment | Yes |
| Secondary | 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. | No | |
| Secondary | 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. | No | |
| Secondary | Colostomy rate | Within 1 year after the end of the treatment. | Yes |