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Trial Title:
Short-course Preoperative Chemoradiotherapy for Rectal Cancer
NCT ID:
NCT01431599
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Locally advanced rectal cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
short-course radiation
Description:
33Gy/10 fractions
Arm group label:
short-course
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
National Cancer Center, Korea
Address:
City:
Goyang
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Dae Yong Kim, MD
Email:
radiopiakim@hanmail.net
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hee Chul Park, MD
Email:
hee.ro.park@samsung.com
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eui Kyu Chie, MD
Email:
ekchie93@SNU.ac.kr
Start date:
September 2011
Completion date:
October 2017
Lead sponsor:
Agency:
Jong Hoon Lee
Agency class:
Other
Collaborator:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Samsung Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Center, Korea
Agency class:
Other
Source:
Seoul St. Mary's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01431599
