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

NCT00931203 | Completed Phase 2 DMC

• 1 other identifier: T2207
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Secondary Outcomes (4)

• 1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.

  > 28 weeks

• Negative resection margins (circumferential resection margin) rate.

  > 28 weeks

• Downstaging rate.

  > 28 weeks

• Sphincter preservation rate.

  > 28 weeks

Interventions

Celecoxib DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with resectable or potentially resectable adenocarcinoma of the rectum.
• 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.
• Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube.
• Age greater than 18 years and \< 80 years, ECOG performance status \< 2
• Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction.
• 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.
• Informed consent signed.

You may not qualify if:

• Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy.
• History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix).
• Pregnancy.
• Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU.
• Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction.
• History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
• Use of aspirin, other NSAID or celecoxib in the two weeks prior to study entry.
• Patients taking warfarin or other anticoagulating medicine.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Changhua Christian Hospital: collaborator
• Chi Mei Medical Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Mackay Memorial Hospital: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lin Wei Wang, MD

  National Health Research of Institutes, Taiwan Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: July 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2013
• Last Updated: May 4, 2016

Record last verified: 2009-07

Locations

TW (1)