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

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Rectal Cancer
• Intervention / Treatment: Drug: Celecoxib

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: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Mackay Memorial Hospital; Chang Gung Memorial Hospital; Taipei Veterans General Hospital, Taiwan; National Cheng-Kung University Hospital; Changhua Christian Hospital; Taichung Veterans General Hospital; Chi Mei Medical Hospital
• Investigators: Principal Investigator: Lin Wei Wang, MD, National Health Research of Institutes, Taiwan Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (ESTIMATE): July 2, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 3, 2016
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: T2207