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

Locally Advanced Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931203
• Other study ID #: T2207
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2009
• Last updated: May 3, 2016
• Start date: July 2008
• Est. completion date: April 2013

Study information

• Verified date: July 2009
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (8)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, Taichung Veterans General Hospital, Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.		> 28 weeks	Yes
Secondary	Negative resection margins (circumferential resection margin) rate.		> 28 weeks	Yes
Secondary	Downstaging rate.		> 28 weeks	Yes
Secondary	Sphincter preservation rate.		> 28 weeks	Yes