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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
Zhongnan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 28, 2015
    Last Updated
    July 10, 2015
    Sponsor
    Zhongnan Hospital
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    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

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    Citation
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    PubMed Identifier
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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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