- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431599
Short-course Preoperative Chemoradiotherapy for Rectal Cancer (KROG 11-02)
October 8, 2017 updated by: Jong Hoon Lee
Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jong Hoon Lee, MD
- Phone Number: 82-010-8607-1269
- Email: koppul@catholic.ac.kr
Study Locations
-
-
-
Goyang, Korea, Republic of
- Recruiting
- National Cancer Center, Korea
-
Contact:
- Dae Yong Kim, MD
- Email: radiopiakim@hanmail.net
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Contact:
- Eui Kyu Chie, MD
- Email: ekchie93@SNU.ac.kr
-
Seoul, Korea, Republic of
- Recruiting
- Samsung Medical Center
-
Contact:
- Hee Chul Park, MD
- Email: hee.ro.park@samsung.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically confirmed adenocarcinoma
- distal margin of the tumor located < 8 cm above the anal verge
- cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
- patient older than age 18 years
- Karnofsky performance score >= 70
Exclusion Criteria:
- distant metastasis identified during staging workup
- previous or concurrent malignancy
- pregnant or breast-feeding women
- impending rectal obstruction
- familial adenomatous polyposis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: short-course
|
33Gy/10 fractions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
downstaging effect of tumor
Time Frame: an expected average of 6 weeks after chemoradiation
|
Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)
|
an expected average of 6 weeks after chemoradiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bladder and small bowel toxicity after chemoradiation
Time Frame: Participants will be followed for an expected average of 3 months 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hong Seok Jang, MD, Department fo Radiation Oncology, Seoul St. Mary's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: N Engl J Med 1997 May 22;336(21):1539.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
September 6, 2011
First Submitted That Met QC Criteria
September 7, 2011
First Posted (Estimate)
September 9, 2011
Study Record Updates
Last Update Posted (Actual)
October 10, 2017
Last Update Submitted That Met QC Criteria
October 8, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KROG 11-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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