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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •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 ≤
- •Previously pelvic radiotherapy.
研究组 & 干预措施
Chemo-radiotherapy
Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
干预措施: Capecitabine (Drug)
Chemo-radiotherapy
Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
干预措施: Mitomycins (Drug)
Chemo-radiotherapy
Capecitabine, PO, 825mg/m2 Mitomycin C, IV, 15 mg/m2 Radiotherapy - 50,4 - 54 Gy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
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.
时间窗: 6 months of the end of radiotherapy and chemotherapy.
次要结局
- Treatment Toxicity(Weekly during the treatment and ultil 28 days after the last dose of capecitabine or ultil the resolution of all adverse events.)
- Complete Response(4 weeks after the end of the treatment)
- 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.)
- 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.)
- Colostomy rate(Within 1 year after the end of the treatment.)