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Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer

NCT00931203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2016-05-04

No results posted yet for this study

Summary

This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free survival and overall survival.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

Celecoxib

Celecoxib (400 mg/d) will be continued from day 1 to 65

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Changhua Christian Hospital

    collaborator OTHER

  • Chi Mei Medical Hospital

    collaborator OTHER

  • Taichung Veterans General Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Mackay Memorial Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Lin Wei Wang, MD · National Health Research of Institutes, Taiwan Cooperative Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-06-30
Completion
2013-04-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931203 on ClinicalTrials.gov