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Clinical Trials/NCT01431599
NCT01431599
Unknown
Phase 2

Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)

Jong Hoon Lee3 sites in 1 country80 target enrollmentSeptember 2011
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ConditionsRectal Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Jong Hoon Lee
Enrollment
80
Locations
3
Primary Endpoint
downstaging effect of tumor
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Jong Hoon Lee

Dr.

Seoul St. Mary's Hospital

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

Outcomes

Primary Outcomes

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 (+)

Secondary Outcomes

  • bladder and small bowel toxicity after chemoradiation(Participants will be followed for an expected average of 3 months after chemoradiation)

Study Sites (3)

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