Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Collaborators: Hoffmann-La Roche; Sanofi-Synthelabo
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

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 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