Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preoperative short-course radiotherapy with local boost
preoperative short-course radiotherapy without local boost
TME surgery
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Local advanced rectal cancer (TNM Stage :T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography .
- distance between tumour and anal edge ≤12cm.
- PS((Performance Status) score 0-2 or Karnofsky score≥70.
- liver and kidney functions are normal.
- without any treatment before inclusion.
Exclusion Criteria:
- metastasis
- combined with other severe diseases,such as other kind of cancer ,COPD,myocardial infarction,ect.
- include in other clinical trails.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
Preoperative short-course radiotherapy with local boost ,the dose of radiotherapy is PTV-CTV 25Gy/5F with local boost of PTV-GTV 30Gy/5F. TME surgery after radiotherapy.
Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost. TME surgery after radiotherapy.
Outcomes
Primary Outcome Measures
pathological complete remission rate
Secondary Outcome Measures
disease free survival
sphincter retention rate
toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events,CTCAE v3.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02498353
Brief Title
Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer
Official Title
Preoperative Short-course Radiotherapy With Local Boost Versus Conventional Preoperative Short-course Radiotherapy for Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.
Detailed Description
The study plans to recruit 100 patients,randomized into study group and control group,patients in study group are given the dose of PTV(planned target volume)-CTV(clinical target volume) 25Gy/5F with a local boost of PTV-GTV(gross tumour volume) 30Gy/5F;patients in control group are given the dose of PTV-CTV 25Gy/5F without a local boost. The other inventions are the same during the whole treatment,after the radiotherapy,they will receive a surgery under TME((total mesorectal excision) principal.Comparing the toxicity of radiotherapy, R0 resection rate,pathological complete remission rate, complications of operation and sphincter retention rate of these two groups to find out weather local boost bringing benefits to patients with local advanced rectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Preoperative short-course radiotherapy with local boost ,the dose of radiotherapy is PTV-CTV 25Gy/5F with local boost of PTV-GTV 30Gy/5F.
TME surgery after radiotherapy.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost.
TME surgery after radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
preoperative short-course radiotherapy with local boost
Intervention Description
Except the clinical target volume(CTV),a gross tumour volume(GTV)is delineated,and give a dose of PTV-GTV:30Gy/5F
Intervention Type
Radiation
Intervention Name(s)
preoperative short-course radiotherapy without local boost
Intervention Description
Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F
Intervention Type
Procedure
Intervention Name(s)
TME surgery
Intervention Description
both study group and control group received surgery under TME principle after radiotherapy
Primary Outcome Measure Information:
Title
pathological complete remission rate
Time Frame
4 weeks after the surgery
Secondary Outcome Measure Information:
Title
disease free survival
Time Frame
From date of randomization until the date of first documented progression,assessed up to 60 months
Title
sphincter retention rate
Time Frame
4 weeks after the surgery
Title
toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events,CTCAE v3.0)
Time Frame
up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Local advanced rectal cancer (TNM Stage :T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography .
distance between tumour and anal edge ≤12cm.
PS((Performance Status) score 0-2 or Karnofsky score≥70.
liver and kidney functions are normal.
without any treatment before inclusion.
Exclusion Criteria:
metastasis
combined with other severe diseases,such as other kind of cancer ,COPD,myocardial infarction,ect.
include in other clinical trails.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuxiang Zhou, professor
Phone
8618971252780
Email
happyzhoufx@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Xia, doctor
Phone
8618971250716
Email
22425583@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuxiang Zhou, professor
Organizational Affiliation
Wuhan University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
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Citation
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Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer
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