Clinical trial NCT02498353: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: pathological complete remission rate
timeFrame: 4 weeks after the surgery
Secondary outcomes:
measure: disease free survival
timeFrame: From date of randomization until the date of first documented progression，assessed up to 60 months
measure: sphincter retention rate
timeFrame: 4 weeks after the surgery
measure: toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events，CTCAE v3.0)
timeFrame: up to 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Zhongnan Hospital
name: Fuxiang Zhou, professor
role: STUDY_DIRECTOR
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