Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer

July 10, 2015 updated by: Zhou Fuxiang, Zhongnan Hospital

Preoperative Short-course Radiotherapy With Local Boost Versus Conventional Preoperative Short-course Radiotherapy for Rectal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ling Xia, doctor
  • Phone Number: 8618971250716
  • Email: 22425583@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group

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.
Radiation: preoperative short-course radiotherapy with local boost
Except the clinical target volume(CTV),a gross tumour volume（GTV）is delineated，and give a dose of PTV-GTV:30Gy/5F
Procedure: TME surgery
both study group and control group received surgery under TME principle after radiotherapy
Active Comparator: control group

Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost.

TME surgery after radiotherapy.
Procedure: TME surgery
both study group and control group received surgery under TME principle after radiotherapy
Radiation: preoperative short-course radiotherapy without local boost
Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pathological complete remission rate
Time Frame: 4 weeks after the surgery
4 weeks after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: From date of randomization until the date of first documented progression，assessed up to 60 months
From date of randomization until the date of first documented progression，assessed up to 60 months
sphincter retention rate
Time Frame: 4 weeks after the surgery
4 weeks after the surgery
toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events，CTCAE v3.0)
Time Frame: up to 60 months
up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Study Director: Fuxiang Zhou, professor, Wuhan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

June 28, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZNHCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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