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)

Conditions: ocally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum.

Registration Number: EUCTR2004-002358-72-AT

Lead Sponsor: Austrian Breast and Colorectal Cancer Study Group (ABCSG)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

- 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

Exclusion Criteria

- 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