Status:
UNKNOWN
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Locally Advanced Malignant Neoplasm
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be benef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01871363
Start Date
October 1 2012
Last Update
June 6 2013
Active Locations (1)
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1
Cancer Hospital, CAMS
Beijing, China, 100021