Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
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|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|
|Primary Completion Date :||February 2012|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|