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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Samsung Medical Center | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
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The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short-course | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short-course radiation | Radiation | 33Gy/10 fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| downstaging effect of tumor | Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+) | an expected average of 6 weeks after chemoradiation |
| Measure | Description | Time Frame |
|---|---|---|
| bladder and small bowel toxicity after chemoradiation | The incidence of grade 3 or higher small bowel and bladder toxicity according to the RTOG and EORTC toxicity criteria (reference: Cox JD et al. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6) | Participants will be followed for an expected average of 3 months after chemoradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Hoon Lee, MD | Contact | 82-010-8607-1269 | koppul@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hong Seok Jang, MD | Department fo Radiation Oncology, Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Recruiting | Goyang | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9091798 | Background | Swedish Rectal Cancer Trial; Cedermark B, Dahlberg M, Glimelius B, Pahlman L, Rutqvist LE, Wilking N. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997 Apr 3;336(14):980-7. doi: 10.1056/NEJM199704033361402. | |
| 3056288 | Background | Gerard A, Buyse M, Nordlinger B, Loygue J, Pene F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC). Ann Surg. 1988 Nov;208(5):606-14. doi: 10.1097/00000658-198811000-00011. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| 24411228 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |