Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Locally Advanced Malignant Neoplasm
About this trial
This is an interventional treatment trial for Locally Advanced Malignant Neoplasm focused on measuring Preoperative Chemoradiotherapy, Bevacizumab, Locally Advanced Rectal Cancer
Eligibility Criteria
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
Sites / Locations
- Cancer Hospital, CAMSRecruiting
Arms of the Study
Arm 1
Experimental
preoperative chemoradiation
radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel. capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends), bevacizumab: at dose 5 mg/kg on days -1, 15,31. Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation.