Preoperative combined radiochemotherapy for patients with newly diagnosed, primary operable and locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum - Studie R02 (95)

Austrian Breast and Colorectal Cancer Study Group (ABCSG)0 个研究点目标入组 60 人开始时间: 2004年10月27日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•- Age: 18 - 80
•- Bioptical 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-controll pill, loop, condom) during and at least 3 month after closure of the studie
•- Life expactancy of at least 3 month
•- Signed written Informed Consent before recruitement
•- Exclusion of distant metastases at the time of recruitement
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- 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 arhythmia, 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

发起方

Austrian Breast and Colorectal Cancer Study Group (ABCSG)