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

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Radiation: preoperative short-course radiotherapy without local boost; Radiation: preoperative short-course radiotherapy with local boost; Procedure: TME surgery

• Registration Number: NCT02498353
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Study First Submitted: 2015-06-28
• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-10
• Last Update Submitted: 2015-07-10
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	TME surgery	Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost. TME surgery after radiotherapy.
control group	preoperative short-course radiotherapy without local boost	Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost. TME surgery after radiotherapy.
study group	TME surgery	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.
study group	preoperative short-course radiotherapy with local boost	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.

Primary Outcome Measures

Name	Time	Method
pathological complete remission rate	4 weeks after the surgery

Secondary Outcome Measures

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