Central and East European Oncology Group

ACELUNG - Phase III trial evaluating the role of adjuvant celecoxib in completely resected, high-risk (pN1-2) non-small-cell lung cancer (NSCLC) patients.

Study start date

2004

Study status

closed

Locations

Poland, Medical University of Gdansk

Sponsors and Collaborators:

  • Medical University of Gdansk
  • Central and Eastern European Oncology Group
  • Stowarzyszenie Ludzi Wyleczonych z Raka Płuca
  • Pharmacia

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

Publication:

  • A. Kukowska, R. Dziadziuszko, J. Jassem, Phase III trial evaluating the role of adjuvant celecoxib in completely resected, high-risk (pN1-2) non-small-cell lung cancer (NSCLC) patients : study progress report, Lung Cancer 2004; vol. 45, suppl. 3, s. S49-S50

CONTACT

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Medical University of Gdańsk
Department of Oncology and Radiotherapy
7 Dębinki Street, 80-211 Gdańsk, Poland
   
email   
phone: +48 58 349 22 54
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