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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00931203
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : May 4, 2016
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Changhua Christian Hospital
Chi Mei Medical Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Mackay Memorial Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

Tracking Information
First Submitted Date  ICMJE July 1, 2009
First Posted Date  ICMJE July 2, 2009
Last Update Posted Date May 4, 2016
Study Start Date  ICMJE July 2008
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2009)
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer. [ Time Frame: 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00931203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2009)
  • 1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer. [ Time Frame: > 28 weeks ]
  • Negative resection margins (circumferential resection margin) rate. [ Time Frame: > 28 weeks ]
  • Downstaging rate. [ Time Frame: > 28 weeks ]
  • Sphincter preservation rate. [ Time Frame: > 28 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
Official Title  ICMJE A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
Brief 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.
Detailed Description

The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.

The secondary objectives of this study are to determine:

  1. Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
  2. Negative resection margins (circumferential resection margin) rate.
  3. Downstaging rate.
  4. Sphincter preservation rate
  5. Locoregional and distant failure rate.
  6. Overall survival
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Rectal Cancer
Intervention  ICMJE Drug: Celecoxib
Celecoxib (400 mg/d) will be continued from day 1 to 65
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2009)
48
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with resectable or potentially resectable adenocarcinoma of the rectum.
  2. Clinical stage by Magnetic Resonance Image (MRI) of pelvis, ultrasonography of liver and Chest X ray: AJCC T2 N1-2M0 or T3-4 N0-2M0 (patients who require diverting loop colostomy are eligible). Nuclear medicine study (whole body bone scan or PET scan) can be performed if clinically indicated.
  3. Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube.
  4. Age greater than 18 years and < 80 years, ECOG performance status < 2
  5. Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction.
  6. WBC > 3.5 x109/L, neutrophil count > 1.5x109/L, platelet count > 100x109/L, serum bilirubin < 1.25xULN (upper limit of normal), AST/ALT < 3x ULN, serum creatinine < 1.25xULN.
  7. Informed consent signed.

Exclusion Criteria:

  1. Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy.
  2. History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix).
  3. Pregnancy.
  4. Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU.
  5. Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction.
  6. History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
  7. Use of aspirin, other NSAID or celecoxib in the two weeks prior to study entry.
  8. Patients taking warfarin or other anticoagulating medicine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00931203
Other Study ID Numbers  ICMJE T2207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Health Research Institutes, Taiwan
Study Sponsor  ICMJE National Health Research Institutes, Taiwan
Collaborators  ICMJE
  • Taipei Veterans General Hospital, Taiwan
  • Changhua Christian Hospital
  • Chi Mei Medical Hospital
  • Taichung Veterans General Hospital
  • National Cheng-Kung University Hospital
  • Chang Gung Memorial Hospital
  • Mackay Memorial Hospital
Investigators  ICMJE
Principal Investigator: Lin Wei Wang, MD National Health Research of Institutes, Taiwan Cooperative Oncology Group
PRS Account National Health Research Institutes, Taiwan
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP