Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Rate of T-downstaging (Reduction of the T-stadium)
研究概览
简要总结
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
详细描述
About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited.
The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 80
- •Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge)
- •According to MRI tumor extensions into the perirectal fat tissue (cT3)
- •No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma
- •WHO performance status 0 - 2
- •Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml)
- •Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
- •Adequate renal function (creatinin - not more than 1.5 mg/dl)
- •Women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
- •Willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study
- •Life expectancy of at least 3 month
- •Signed written Informed Consent before recruitment
- •Exclusion of distant metastases at the time of recruitment
排除标准
- •Former radio- and/or chemotherapy
- •Tumor of the upper rectum
- •Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma)
- •Peripheral Neuropathy (NCI CTC - not higher than Grade 1)
- •General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine
- •Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders
- •Florid, serious infection at the time of recruitment
- •Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance
- •Evidence of lacking willingness for cooperation of the patient
- •Pregnant or breast feeding women
研究组 & 干预措施
single arm (radiochemotherapy)
single arm study (capecitabine, oxaliplatin)
干预措施: Capecitabine (Drug)
single arm (radiochemotherapy)
single arm study (capecitabine, oxaliplatin)
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Rate of T-downstaging (Reduction of the T-stadium)
时间窗: at the time of final surgery
surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
次要结局
- Evaluation of the toxicity grade III and IV of the therapy scheme(week 1 to max. week 10)