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Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients

NCT00211952 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2005-09-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

celecoxib

Sponsors & Collaborators

  • Central and Eastern European Oncology Group

    collaborator OTHER

  • Stowarzyszenie Ludzi Wyleczonych z Raka Płuca

    collaborator UNKNOWN

  • Pharmacia

    collaborator INDUSTRY

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Jacek Jassem, Professor · Medical University of Gdansk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211952 on ClinicalTrials.gov