Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
1 other identifier
interventional
104
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 4, 2015
February 1, 2015
1.9 years
July 11, 2014
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Pathological complete remission rate (pCR)
after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Secondary Outcomes (1)
Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
during preoperative treatment and after surgery for 5 years
Other Outcomes (1)
• Disease-free survival
3 year afte concurrent chemoradiation
Study Arms (2)
conventional fraction
ACTIVE COMPARATORRadiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily
SIB
EXPERIMENTALConcomitant 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
Interventions
capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
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
Eligibility Criteria
You may qualify if:
- histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
- the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound
You may not qualify if:
- metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status \> 3
- patients not deemed fit for radiotherapy, capecitabine or surgery
- pregnant or lactating patients
- women with child bearing potential who lack effective contraception
- patients below 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital, CAMS
Beijing, 100021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jing Jin, proffessor
Dept of Radiation oncology, Cancer hospital, CAMS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 21, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 4, 2015
Record last verified: 2015-02