Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Inclusion Criteria:
- Male or female patients with histologically proven adenocarcinoma of the rectum ,T3/4
or any node positive disease (clinical stage according the TNM classification system)
- No evidence of metastatic disease.
- Age 18 - 65 years
- Kps 80-100
- No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
- Normal 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 Criteria:
- Malignancy of the rectum other than adenocarcinoma
- 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)
- Evidence of active peptic ulcer or upper GI bleeding
- Evidence of bleeding diathesis or coagulopathy
- Patients receiving a concomitant treatment with drugs interacting with
capecitabine such as flucitosine, phenytoin, or warfarin
- Known hypersensitivity to biological drugs
- Treatment with any investigational drug within 30 days before beginning
treatment with the study drug
- Pregnant or lactating patient