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Short-course Preoperative Chemoradiotherapy for Rectal Cancer (KROG 11-02)

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
short-course radiation
Sponsored by
Jong Hoon Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Locally advanced rectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Cancer Center, KoreaRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

short-course

Arm Description

Outcomes

Primary Outcome Measures

downstaging effect of tumor
Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)

Secondary Outcome Measures

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)

Full Information

First Posted
September 6, 2011
Last Updated
October 8, 2017
Sponsor
Jong Hoon Lee
Collaborators
Seoul National University Hospital, Samsung Medical Center, National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01431599
Brief Title
Short-course Preoperative Chemoradiotherapy for Rectal Cancer
Acronym
KROG 11-02
Official Title
Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jong Hoon Lee
Collaborators
Seoul National University Hospital, Samsung Medical Center, National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Locally advanced rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
short-course
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
short-course radiation
Intervention Description
33Gy/10 fractions
Primary Outcome Measure Information:
Title
downstaging effect of tumor
Description
Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)
Time Frame
an expected average of 6 weeks after chemoradiation
Secondary Outcome Measure Information:
Title
bladder and small bowel toxicity after chemoradiation
Description
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)
Time Frame
Participants will be followed for an expected average of 3 months after chemoradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Hoon Lee, MD
Phone
82-010-8607-1269
Email
koppul@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Seok Jang, MD
Organizational Affiliation
Department fo Radiation Oncology, Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Yong Kim, MD
Email
radiopiakim@hanmail.net
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Chul Park, MD
Email
hee.ro.park@samsung.com
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eui Kyu Chie, MD
Email
ekchie93@SNU.ac.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
9091798
Citation
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.
Results Reference
background
PubMed Identifier
3056288
Citation
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.
Results Reference
background
PubMed Identifier
24411228
Citation
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.
Results Reference
derived

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Short-course Preoperative Chemoradiotherapy for Rectal Cancer

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