Locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum.
Conditions
Sponsors
Austrian Breast and Colorectal Cancer Study Group (ABCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine);Secondary Objective: Evaluation of the toxicity grade III and IV of the therapy scheme ;Primary end point(s): Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) | — |
Countries
Austria
Outcome results
None listed