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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02498353

Enrollment

100

Registered

2015-07-15

Start date

2015-07-31

Completion date

2020-05-31

Last updated

2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

RADIATIONpreoperative 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

RADIATIONpreoperative short-course radiotherapy without local boost

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

PROCEDURETME surgery

both study group and control group received surgery under TME principle after radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
pathological complete remission rate	4 weeks after the surgery

Secondary

Measure	Time frame
toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events，CTCAE v3.0)	up to 60 months
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

Contacts

Primary ContactFuxiang Zhou, professor

happyzhoufx@sina.com8618971252780

Backup ContactLing Xia, doctor

22425583@qq.com8618971250716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026