Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Conditions
Locally Advanced Malignant Neoplasm
Conditions: official terms
Neoplasms
Conditions: Keywords
Preoperative Chemoradiotherapy, Bevacizumab, Locally Advanced Rectal Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: chemoradiation
Type: Radiation
Overall Status
Recruiting
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 beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Cancer Hospital, CAMS
Beijing, China
Status: Recruiting
Contact: Jing Jin, proffessor - 8610-87788280 - jingjin1025@163.com
Start Date
October 2012
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page