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

Conditions: ocally advanced rectal cancer

Registration Number: EUCTR2008-002902-20-SI

Lead Sponsor: Onkološki inštitut Ljubljana

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

•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
-Urine dipstick of proteinuria <2+. Patients discovered to have =2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate =1 g of protein/24 hr
-
•Ability to swallow tablets
•Signed informed consent
•Patients must be willing and able to comply with the protocol for duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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
•History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures
•Serious, non-healing wound, ulcer or bone fracture
• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or lack of complete recovery
•Acute intra abdominal inflammatory process

•Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of nvestigational drug or puts the patient at high risk for treatment-related complications
•Patients receiving a concomitant treatment with drugs interacting with capecitabin such as flucitosine, phenytoin, or warfarin
•Known dihydropyrimidine dehydrogenase (DPD) deficiency
•Known hypersensitivity to study drug
•Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
•Life expectancy less than 3 months
•Pregnant or lactating patient
•Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years, hysterectomy or oophorectomy)