Status:
SUSPENDED
Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients
Lead Sponsor:
Medical University of Gdansk
Collaborating Sponsors:
Central and Eastern European Oncology Group
Stowarzyszenie Ludzi Wyleczonych z Raka Płuca
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (p...
Detailed Description
1. Rationale and objectives To assess the influence of celecoxib on relapse-free survival in completely resected patients with poor prognosis indicated by metastatic involvement of intrapulmonary/...
Eligibility Criteria
Inclusion
- Eligibility criteria:
- Completely resected (R0), histologically confirmed NSCLC with pathological T1-T3 category and pathological proof of N1 or N2 disease
- Adequate pre-surgical disease assessment (chest CT and upper abdominal CT - mandatory; mediastinoscopy or PET mandatory if clinical N2 is suspected on chest CT; other examinations according to signs and symptoms to exclude metastatic disease)
- Adequate lymph node sampling
- Randomization between 14 and 42 days after surgery
- Adequate post-surgical recovery
- Age \> 18 years
- WHO Performance Status 0 or 1
- Adequate liver and renal function (ALT \< 1.5 ULN, bilirubin within normal limits, creatinine \< 1.5 ULN) and adequate haematology (haemoglobin \>11g/dL, WBC\>2.000/L, PLT\>100.000/L)
- Written informed consent
- No previous treatment with chemotherapy
- No histological diagnosis of SCLC or mixed NSCLC/SCLC type
- No apparent involvement of mediastinal lymph nodes at preoperative staging (cN2)
- No evidence of metastatic disease (M1)
- Stable medical conditions (e.g. no myocardial infarction within 12 months, unstable angina, active psychiatric disorder)
- No active infection
- No history of malignancy other than basal-cell skin cancer or in situ cervical cancer
- No history of severe renal or liver insufficiency
- No history of a recent gastrointestinal bleeding or active ulcer disease or extensive gastro-intestinal surgery that may affect the drug absorption
- No participation in any investigational study within 30 days prior to enrollment
- No pregnancy or lactation or inadequate contraception
- No known hypersensitivity to celecoxib, other COX-2 inhibitors or aspirin (aspirin triad)
- No chronic use of NSAID's (selective inhibitors of COX-2 and non- selective COX inhibitors), acetylsalicylic acid (aspirin) nor oral steroids \>14 days during one month prior to surgery nor anticipated chronic use of the above drugs during the study
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
542 Patients enrolled
Trial Details
Trial ID
NCT00211952
Start Date
March 1 2004
Last Update
September 21 2005
Active Locations (1)
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1
Medical University of Gdansk
Gdansk, Poland, 80-211