Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Health Research Institutes, Taiwan.
Recruitment status was Recruiting
Recruitment status was Recruiting
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 at Linkou
Chang Gung Memorial Hospital at Chiayi
Chang Gung Memorial Hospital at Kaohsiung
Mackay Memorial Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00931203
First received: July 1, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Locally Advanced Rectal Cancer |
Drug: Celecoxib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer |
Resource links provided by NLM:
Further study details as provided by National Health Research Institutes, Taiwan:
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. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]
- Negative resection margins (circumferential resection margin) rate. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]
- Downstaging rate. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]
- Sphincter preservation rate. [ Time Frame: > 28 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 48 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Celecoxib
Celecoxib (400 mg/d) will be continued from day 1 to 65
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931203
Contacts
| Contact: Yung Hsin Chin, MSN | +886-37-246166 ext 35119 | yhchin@nhri.org.tw |
Locations
| Taiwan | |
| Mackay Memorial Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Hao Hsien Lee, MD +886-6-2812811 ext 7109 cmh7000@mail.chimei.org.tw | |
| Contact: Yee Chao, MD PHD +886-2-28757270 ext 207, 250 ychao@vghtpe.gov.tw | |
| Sub-Investigator: Jeng- Yi Wang, MD PHD | |
| Principal Investigator: Tzu Chi Hsu, MD | |
Sponsors and Collaborators
National Health Research Institutes, Taiwan
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 at Linkou
Chang Gung Memorial Hospital at Chiayi
Chang Gung Memorial Hospital at Kaohsiung
Mackay Memorial Hospital
Investigators
| Principal Investigator: | Lin Wei Wang, MD | National Health Research of Institutes, Taiwan Cooperative Oncology Group |
More Information
No publications provided
| Responsible Party: | Chin, Yung-Hsin / Research Nurse, National Health Research Instiutes/Taiwan Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00931203 History of Changes |
| Other Study ID Numbers: | T2207 |
| Study First Received: | July 1, 2009 |
| Last Updated: | July 1, 2009 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013