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.
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.
Anal Canal Cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- 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. ] [ Designated as safety issue: No ]
- Treatment Toxicity [ Time Frame: Weekly during the treatment and ultil 28 days after the last dose of capecitabine or ultil the resolution of all adverse events. ] [ Designated as safety issue: Yes ]Adverse events grade 3 and 4 according to CTCAE 3.0 (Common Toxicity Criteria for Adverse Effects).
- Complete Response [ Time Frame: 4 weeks after the end of the treatment ] [ Designated as safety issue: Yes ]Complete response rate 4 weeks after completion of chemotherapy and radiation therapy.
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Colostomy rate [ Time Frame: Within 1 year after the end of the treatment. ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
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.Drug: Mitomycins
15 mg/m2, IV, bolus, single dose on day 1 of radiotherapyRadiation: Radiotherapy
Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks
|Contact: Paulo MG Hoff, PHD||55 11 firstname.lastname@example.org|
|Sao Paulo, SP, Brazil, 01246000|
|Contact: Paulo MD Hoff, PHD 55 11 38932000 email@example.com|
|Principal Investigator: Paulo MD Hoff, PHD|
|Principal Investigator:||Paulo MG Hoff, PHD||Instituto do Cancer do Estado de São Paulo|