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

Zhongnan Hospital

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: TME surgery; Radiation: preoperative short-course radiotherapy with local boost; Radiation: preoperative short-course radiotherapy without local boost

Study type: Interventional

Funder types: Other

Identifiers

NCT02498353

ZNHCR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

study group

Experimental group

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.

Treatment:

Procedure: TME surgery

Radiation: preoperative short-course radiotherapy with local boost

control group

Active Comparator group

Description:

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

Treatment:

Radiation: preoperative short-course radiotherapy without local boost

Procedure: TME surgery