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The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.
1.1 experimental arm Two-week course concurrent chemoradiotherapy
Radiotherapy, 33 Gy/10 fractions for 2 weeks
↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12
Capecitabine 825 mg/m2, twice daily
1.2 control arm
Standard concurrent chemoradiotherapy (CRT)
Radiotherapy, 50.4 Gy/28 fractions for 6 weeks
↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38
Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5
Capecitabine, 825 mg/ m2, bid
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-week course arm | Experimental | Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine. Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid |
|
| Conventional arm | No Intervention | conventionally fractionated radiation of 50.4 Gy/28 fx and 5-FU, 500 mg/m2 and leucovorin, 20 mg/m2 for 5 days, monthly or Capecitabine, 825 mg/m2, bid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-week course of radiation | Radiation | 33 Gy in 10 fractions for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response from stage II-III to stage 0-I | Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0) | from clinical staging time to radical surgery date (about 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity (acute and chronic) | During the course of radiotherapy, patients were evaluated weekly to assess acute toxicity. Patients were also followed 2 and 4 weeks after completion of radiotherapy and until 3 years after curative surgery to assess toxicity. Toxicity are assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). | from radiation start to 3 years after radical surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Hoon Lee, MD | Contact | +82-031-249-8440 | koppul@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jong Hoon Lee, MD | St. Vincent's Hospital, The Catholic University of Kora | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lee Jong Hoon | Recruiting | Suwon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24411228 | Result | Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7. |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Two-week course of radiation | Drug | oral capecitabine, 825mg/m2, bid |
|
|
| Recurrence and survival | 3-year recurrence-free survival and 3-year overall survival |