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 sites60 target enrollmentOctober 27, 2004

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ocally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum.
Sponsor: Austrian Breast and Colorectal Cancer Study Group (ABCSG)
Enrollment: 60
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

October 27, 2004

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Austrian Breast and Colorectal Cancer Study Group (ABCSG)

•\- 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

•\- 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