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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00931203
First received: July 1, 2009
Last updated: May 3, 2016
Last verified: July 2009
  Purpose
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.

Condition Intervention Phase
Locally Advanced Rectal Cancer
Drug: Celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]
  • Negative resection margins (circumferential resection margin) rate. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]
  • Downstaging rate. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]
  • Sphincter preservation rate. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: July 2008
Study Completion Date: April 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Celecoxib
    Celecoxib (400 mg/d) will be continued from day 1 to 65
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931203

Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
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
Principal Investigator: Lin Wei Wang, MD National Health Research of Institutes, Taiwan Cooperative Oncology Group
  More Information

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00931203     History of Changes
Other Study ID Numbers: T2207 
Study First Received: July 1, 2009
Last Updated: May 3, 2016
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 24, 2016