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

Official Title: “A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer”

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.

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

Intervention(s) in this Clinical Trial

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

Primary 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
    Safety Issue?: Yes

Secondary Measures

• 1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
  • Time Frame: > 28 weeks
    Safety Issue?: Yes
• Negative resection margins (circumferential resection margin) rate.
  • Time Frame: > 28 weeks
    Safety Issue?: Yes
• Downstaging rate.
  • Time Frame: > 28 weeks
    Safety Issue?: Yes
• Sphincter preservation rate.
  • Time Frame: > 28 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Health Research Institutes, Taiwan Other

Overall Clinical Trial Officials and Contacts

Lin Wei Wang, MD Principal Investigator National Health Research of Institutes, Taiwan Cooperative Oncology Group  

Overall Contact: Yung Hsin Chin, MSN +886-37-246166 yhchin@nhri.org.tw

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931203

Study ID Number: T2207

ClinicalTrials.gov Identifier: NCT00931203

Health Authority: Taiwan: Department of Health