Preoperative Radiotherapy with Capecitabine and Bevacizumab in locally advanced rectal cancer: CRAB Phase II study - CRAB

Onkološki inštitut Ljubljana0 sitesSeptember 19, 2008

Overview

No summary available.

Registry

who.int

Start Date

September 19, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Onkološki inštitut Ljubljana

•Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum), T3/4 or any node positive disease (clinical stage according the TNM classification system)
•No evidence of metastatic disease.
•The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation.
•Age 18 \- 80 years
•WHO Performance Status 0\-2
•No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
•Adequate hematological, hepatic and renal function as following:
•\-ANC \=1\.5 x 109/L and Platelets \=100 x 109/L
•\-Total bilirubin \=1\.5 x the upper\-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and /or ALAT (SGPT) \=2\.5 x UNL, alkaline phosphatase \=2\.5 x UNL
•\-Serum creatinine \=1\.5 x UNL

•Malignancy of the rectum other than adenocarcinoma
•Any unrested synchronous colon cancer
•Other co\-existing malignancy or malignancy within the last 5 years prior to treatment start, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
•Clinically significant cardiovascular disease, for example CVA, myocardial infarction (within 12 months before treatment start), unstable angina, New York Heart Association (NYHA) \> Class II congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension
•Any arterial thromboembolic event within 6 months before start of study
•Any serious venous thromboembolic event within 3 months before study start
•Evidence of active peptic ulcer or upper GI bleeding
•Evidence of bleeding diathesis or coagulopathy
•Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (\> 325 mg/day) or clopidrogel (\> 75 mg/day)
•Current or recent (within 10 days prior to study treatment start) use of full\-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes