Status:
UNKNOWN
Preoperative Radiotherapy With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer: CRAB Phase II Study
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The use of preoperative chemoradiation and adjuvant chemotherapy with 5-FU based chemotherapy reduced local recurrence rate to less than 10%, but has only had limited effect on overall survival due to...
Detailed Description
* radiotherapy: 45 Gy to the pelvis (25x 1.8 Gy on days 1-33, excluding weekends) plus 5.4 Gy on days 36-38 as a boost to the primary tumour (3 fractions of 1.8 Gy).Three- dimensional CT planing and a...
Eligibility Criteria
Inclusion
- 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 Ability to swallow tablets
- Signed informed consent
- Patients must be willing and able to comply with the protocol for duration of the study
Exclusion
- Malignancy of the rectum other than adenocarcinoma
- Any unrested synchronous colon cancer
- Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
- Significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
- Serious, non-healing wound, ulcer or bone fracture
- Evidence of active peptic ulcer or upper GI bleeding
- Evidence of bleeding diathesis or coagulopathy
- Chronic daily treatment with high-dose aspirin(\>325mg/day)
- Current or recent (\>10 days) use of full-dose of parenteral anticoagulants or thrombolytic agents for therapeutic purpose
- Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucitosine, phenytoin, or warfarin
- Known dihydropyrimidine dehydrogenase (DPD)deficiency
- Major surgery within 4 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery or open biopsy
- Known hypersensitivity to biological drugs
- Treatment with any investigational drug within 30 days before beginning treatment with the study drug
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00842686
Start Date
January 1 2009
End Date
August 1 2014
Last Update
March 26 2012
Active Locations (1)
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1
Onstitute of Oncology, Zaloška 2
Ljubljana, Slovenia, 1000