Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
NCT02195141 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2015-02-04
Summary
Pathological complete response, (pCR) correlates with a favorable 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 SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.
Conditions
Interventions
- RADIATION
-
conventional fraction
capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
- RADIATION
-
SIB
Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Jing Jin, proffessor · Dept of Radiation oncology, Cancer hospital, CAMS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- China
Study Locations
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