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Trial Title:
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
NCT ID:
NCT01871363
Condition:
Locally Advanced Malignant Neoplasm
Conditions: Official terms:
Rectal Neoplasms
Neoplasms
Capecitabine
Conditions: Keywords:
Preoperative Chemoradiotherapy
Bevacizumab
Locally Advanced Rectal Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
chemoradiation
Description:
- 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.
Arm group label:
preoperative chemoradiation
Other name:
Preoperative Radiotherapy With Capecitabine and Bevacizumab
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital, CAMS
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Jin, proffessor
Phone:
8610-87788280
Email:
jingjin1025@163.com
Contact backup:
Last name:
Hua Ren, Attening
Phone:
8610-87788122
Email:
renhua2009@hotmail.com
Investigator:
Last name:
Jing Jin, professor
Email:
Principal Investigator
Start date:
October 2012
Lead sponsor:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Source:
ChineseAMS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01871363
