Rectal Cancer
Conditions
Keywords
pilot study, rectal, carcinoma, phase II, preoperative, RadioChemo, molecular, target, therapy, T3, ABCSG, TAKO, R04, 08
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 * collection of response rate (T- and M-downstaging, pathological complete remission)
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 each radiation day during the first 4 weeks RCTx Molecular Targeted Therapy: Bevacizumab 5 mg/kg body weight; day 1, 15, 29 Operation due to TME adherence to a break of min. 42 to max. 56 days after the last application of bevacizumab
Interventions
DRUGcapecitabine, bevacizumab
Capecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29
Sponsors
Hoffmann-La Roche
Austrian Breast & Colorectal Cancer Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma | descriptive evaluation |
Secondary
| Measure | Time frame |
|---|---|
| collection of response rate (T- and M-downstaging, pathological complete remission) | descriptive evaluation |
Countries
Austria
Outcome results
None listed