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Sponsors and Collaborators: |
Medical University of Gdansk Central and Eastern European Oncology Group Stowarzyszenie Ludzi Wyleczonych z Raka Płuca Pharmacia |
Information provided by: | Medical University of Gdansk |
ClinicalTrials.gov Identifier: | NCT00211952 |
The aim of the study is to assess the influence of celecoxib on relapse-free survival in completely resected patients with poor prognosis indicated by metastatic involvement of intrapulmonary/hilar (pN1) or ipsilateral mediastinal (pN2) lymph nodes. Celecoxib, a selective oral COX-2 inhibitor, was found to exert significant anti-proliferative activity against a variety of tumor cell lines in vitro, including NSCLC. COX-2 is frequently up-regulated in NSCLC cell lines and archival tumor samples. Its high expression was also correlated with poor prognosis of the patients. A clinical trial addressing the role of celecoxib as adjuvant treatment in radically operated patients with high risk of relapse is warranted.
Condition | Intervention | Phase |
Non-Small Cell Lung Cancer |
Drug: celecoxib |
Phase III |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled Phase III Trial Evaluating the Role of Adjuvant Celecoxib in Completely Resected, High-Risk (pN1-2) Non-Small Cell Lung Cancer (NSCLC) Patients |
Estimated Enrollment: | 542 |
Study Start Date: | March 2004 |
Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility criteria:
Poland | |||||
Medical University of Gdansk | |||||
Gdansk, Poland, 80-211 |
Medical University of Gdansk |
Central and Eastern European Oncology Group |
Stowarzyszenie Ludzi Wyleczonych z Raka Płuca |
Pharmacia |
Principal Investigator: | Jacek Jassem, Professor | Medical University of Gdansk |
Study ID Numbers: | 0102 PLCSG |
First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00211952 |
Health Authority: | Poland: Ministry of Health |
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