Short-course Preoperative Chemoradiotherapy for Rectal Cancer
NCT ID: NCT01431599
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2011-09-30
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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short-course
short-course radiation
33Gy/10 fractions
Interventions
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short-course radiation
33Gy/10 fractions
Eligibility Criteria
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Inclusion Criteria
2. distal margin of the tumor located \< 8 cm above the anal verge
3. cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
4. patient older than age 18 years
5. Karnofsky performance score \>= 70
Exclusion Criteria
2. previous or concurrent malignancy
3. pregnant or breast-feeding women
4. impending rectal obstruction
5. familial adenomatous polyposis
18 Years
75 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Samsung Medical Center
OTHER
National Cancer Center, Korea
OTHER_GOV
Jong Hoon Lee
OTHER
Responsible Party
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Jong Hoon Lee
Dr.
Principal Investigators
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Hong Seok Jang, MD
Role: PRINCIPAL_INVESTIGATOR
Department fo Radiation Oncology, Seoul St. Mary's Hospital
Locations
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National Cancer Center, Korea
Goyang, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Dae Yong Kim, MD
Role: primary
Hee Chul Park, MD
Role: primary
Eui Kyu Chie, MD
Role: primary
References
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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.
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.
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.
Other Identifiers
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KROG 11-02
Identifier Type: -
Identifier Source: org_study_id