Status:
TERMINATED
Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the ...
Detailed Description
OBJECTIVES: Primary * To determine the potential overall survival benefit of adjuvant chemotherapy in patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy compared...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma)
- Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0
- No status
- Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan
- The mass must have a source document to verify tumor size in the greatest dimension, which includes a CT scan report, a clinic note from the enrolling physician, and/or a printed image with caliper measurements on the lung mass
- Node-negative disease
- Evidence of hilar or mediastinal node involvement by chest CT scan (\> 1 cm diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling before or at time of thoracotomy
- No locally advanced or metastatic disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Granulocytes ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Bilirubin ≤ 1.5 mg/dL
- AST \< 1.5 times upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of prior or concurrent malignancy, except curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease-free for 3 years
- PRIOR CONCURRENT THERAPY:
- More than 3 years since prior cytotoxic or anticancer treatment
- No concurrent treatment with hormones or other chemotherapeutic agents, except steroids given for adrenal failure, hormone administered for nondisease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic
- No concurrent thoracic radiotherapy
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00863512
Start Date
March 1 2009
End Date
November 1 2012
Last Update
March 27 2017
Active Locations (94)
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1
Regional Medical Center
Anniston, Alabama, United States, 36207
2
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
3
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
4
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204