Status:
COMPLETED
Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
Sanofi-Synthelabo
Hoffmann-La Roche
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 toxici...
Detailed Description
About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited. The radiotherapy is an essential part of therapy of the advanced rectal carcin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00297141
Start Date
October 1 2004
End Date
December 1 2013
Last Update
December 31 2013
Active Locations (8)
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1
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, Austria, 9330
2
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
3
Paracelsus Medical University Salzburg - Oncology
Salzburg, Salzburg, Austria, 5020
4
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036