Status:
TERMINATED
Preoperative Combined RadioChemo-Molecular Target Therapy With Capecitabine, Bevacizumab, and Radiotherapy
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
* feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma * collectio...
Detailed Description
Combined RadioChemotherapy: Therapy start: within 28 days after bioptical diagnosis Radiotherapy: 5 x 5 days 1.8 Gy radiotherapy; cummulative dose 45 Gy Chemotherapy: Capecitabin 825mg/m² bid, on e...
Eligibility Criteria
Inclusion
- age: 18 - 80
- bioptical confirmed adenocarcinoma of the rectum in T3NxM0 status. The tumor has to be basically surgically complete resectable (-\>R0).
- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of rectum carcinoma
- WHO performance status 0-2
- adequate bone marrow reserve (granulocytes \>= 3.000/µl, absolute neutrophil \>= 0 1,5 x 10 9/l thrombocytes: \>= 100.000/µl, haemoglobin \>= 10g/dl)
- adequate hepatic function (Bilirubin: \<= 1.5 x ULN, GOT und GPT \<= 2.5 x ULN)
- adequate renal function (creatinin: \<= 1.25 mg/dl, creatinin-clearance: \> 50 ml/min (Cockcroft and Gault formula)), proteinuria: dipstick \< 2+. In case of dipstick \> 2+ protein has to be measured in 24h urine and does not exceed more than 1g/24h)
- ability of intake of pills
- 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 (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study
- life expectancy of at least 3 month
- INR and aPTT \< 1.5 ULN
- signed Informed Consent before recruitment
Exclusion
- failure of one inclusion criteria
- former radiotherapy of pelvis or abdomen
- former chemotherapy
- any other kind of malign tumor in the last 5 years
- any other kind of tumour in the last 5 years with exception of basal cell carcinoma of skin and cervix carcinoma in situ
- general contraindication or known hypersensitivity against Bevacizumab and/or Capecitabine
- non malign disease, if there is a contraindication with radiotherapy, or chemotherapy with Bevacizumab and Capecitabine, or a resection of rectum: uncontrolled hypertension (systolic \> 150 mmHG and/or diastolic \>100 mmHG) or clinical significant (e.g. active) cardiovascular disease: CVA (cardiovascular accident)/ cerebral apoplexy (\< 6 months before recruitment), myocardial infarct (\< 6 months before recruitment), instable angina pectoris, CHF with NYHA status II or higher, or treated serious arrhythmia, hepatic disease, significant neurologic or psychiatric disorders
- florid, serious infections at the time of recruitment
- peripheral neuropathy (NCI CTC \>= Grade 1)
- legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
- evidence of lacking cooperation of the patient
- major intervention within 28 days before recruitment, open wounds
- serious injuries, unhealed wounds or fractures
- patients with spinal compressions or metastases in central nervous system
- evidence of bleeding diathesis or coagulation dysfunction
- actual intake of anticoagulant or thrombolytic agents, Aspirin \> 325 mg/d or within 10 days before study start)
- actual or recent (within 10 days before recruitment) therapeutic therapy with fully-dosed anticoagulants. A prophylactic treatment is permitted.
- previous thromboembolic or hemorrhagic events within the last 6 months before recruitment
- previous abdominal fistulas, GI perforation or intra-abdominal abscess within the last 6 months
- treatment with other study medication within 28 days before recruitment
- patients with malabsorption syndrome or difficulties swallowing
- pregnant or breast feeding women
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00671645
Start Date
July 1 2008
End Date
February 27 2009
Last Update
October 19 2020
Active Locations (10)
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1
Hospital BHB St. Veit/Glan, Surgery
Saint Veit/Glan, Carinthia, Austria, 9300
2
Medical University Graz, Oncology
Graz, Styria, Austria, 8036
3
State Hospital Leoben, Surgery
Leoben, Styria, Austria, 8700
4
Medical University Innsbruck, Internal Medicine
Innsbruck, Tyrol, Austria, 6020