Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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