An interventional study of preoperative short-course radiotherapy with local boost and preoperative short-course radiotherapy without local boost in Rectal Cancer, sponsored by Zhongnan Hospital. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-15.
Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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 · Procedure: 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.
Radiation: preoperative short-course radiotherapy without local boost · Procedure: TME surgery
Except the clinical target volume(CTV),a gross tumour volume（GTV）is delineated，and give a dose of PTV-GTV:30Gy/5F
Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F
both study group and control group received surgery under TME principle after radiotherapy
pathological complete remission rate
Time frame: 4 weeks after the surgery
disease free survival
Time frame: 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
toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events，CTCAE v3.0)
Time frame: up to 60 months
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Zhongnan Hospital