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

Primary Purpose

Locally Advanced Rectal Cancer

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Celecoxib

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Mackay Memorial Hospital

Outcomes

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.

Secondary Outcome Measures

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

Negative resection margins (circumferential resection margin) rate.

Downstaging rate.

Sphincter preservation rate.

Full Information

NCT ID

NCT00931203

First Posted

July 1, 2009

Last Updated

May 3, 2016

Sponsor

National Health Research Institutes, Taiwan

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

1. Study Identification

Unique Protocol Identification Number

NCT00931203

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Health Research Institutes, Taiwan

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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: Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer. Negative resection margins (circumferential resection margin) rate. Downstaging rate. Sphincter preservation rate Locoregional and distant failure rate. Overall survival

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Rectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

> 28 weeks

Title

Negative resection margins (circumferential resection margin) rate.

Time Frame

> 28 weeks

Title

Downstaging rate.

Time Frame

> 28 weeks

Title

Sphincter preservation rate.

Time Frame

> 28 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin Wei Wang, MD

Organizational Affiliation

National Health Research of Institutes, Taiwan Cooperative Oncology Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mackay Memorial Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

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

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