Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
|ClinicalTrials.gov Identifier: NCT01129700|
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : April 27, 2012
Concurrent chemoradiotherapy (CRT)
Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)
↓ ↓ ↓ ↓ ↓
Radical surgery 6 weeks after completion of chemoradiotherapy
- ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5
- 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: Radiation: short-course preoperative chemoradiotherapy||Phase 2|
Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions.
A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy.
Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
|Experimental: short-course CRT-5FU||
Radiation: Radiation: short-course preoperative chemoradiotherapy
Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days).
Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).
- To evaluate the pathologic response [ Time Frame: After surgery with pathology data ]downstaging(ypT0-2N0M0)rate
- Tumor regression grade & MR volumetry [ Time Frame: After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery ]To evaluate the tumor regression grade & MR volumetry
- Acute/ late toxicities [ Time Frame: preoperative CCRT to 3 months after surgery ]To evaluate the acute and late toxicities
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129700
|Korea, Republic of|
|National Cancer Center Korea|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|