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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Locally Advanced Rectal Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

10 weeks

Safety Issue:

Yes

Principal Investigator

Lin Wei Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Health Research of Institutes, Taiwan Cooperative Oncology Group

Authority:

Taiwan: Department of Health

Study ID:

T2207

NCT ID:

NCT00931203

Start Date:

July 2008

Completion Date:

July 2010

Related Keywords:

  • Locally Advanced Rectal Cancer
  • Rectal Neoplasms

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