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Short-course Preoperative Chemoradiotherapy for Rectal Cancer
Conditions
Rectal Cancer
Conditions: official terms
Rectal Neoplasms
Conditions: Keywords
Locally advanced rectal cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: short-course radiation
Type: Radiation
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. histologically confirmed adenocarcinoma
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:
1. distant metastasis identified during staging workup
2. previous or concurrent malignancy
3. pregnant or breast-feeding women
4. impending rectal obstruction
5. familial adenomatous polyposis
1. histologically confirmed adenocarcinoma
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:
1. distant metastasis identified during staging workup
2. previous or concurrent malignancy
3. pregnant or breast-feeding women
4. impending rectal obstruction
5. familial adenomatous polyposis
Locations
National Cancer Center, Korea
Goyang, Korea, Republic of
Samsung Medical Center
Status: Recruiting
Contact: Dae Yong Kim, MD - radiopiakim@hanmail.net
Seoul, Korea, Republic of
Seoul National University Hospital
Status: Recruiting
Contact: Hee Chul Park, MD - hee.ro.park@samsung.com
Seoul, Korea, Republic of
Status: Recruiting
Contact: Eui Kyu Chie, MD - ekchie93@SNU.ac.kr
Start Date
September 2011
Completion Date
October 2017
Sponsors
Seoul St. Mary's Hospital
Source
Seoul St. Mary's Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page