A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Compare the time to recurrence in patients with stage IB or II non-small cell lung
cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and
cisplatin.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of these patients.
- Compare the complete resection rate with and without neoadjuvant gemcitabine
hydrochloride and cisplatin.
OUTLINE: This is a randomized study. Patients are stratified by disease stage (IB vs II) and
histology (squamous cell carcinoma vs nonsquamous cell carcinoma). Patients are randomized
to 1 of 2 treatment arms.
- Arm I (neoadjuvant chemotherapy): Patients receive gemcitabine hydrochloride IV over 30
minutes and cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 4
weeks for up to 4 courses in the absence of disease recurrence or unacceptable
toxicity. Within 8 weeks after initiating course 4 of chemotherapy, patients undergo
complete surgical resection.
- Arm II (adjuvant chemotherapy): Patients undergo complete surgical resection. Beginning
within 8 weeks after complete surgical resection, patients receive gemcitabine
hydrochloride IV and cisplatin IV as in arm I.
Quality of life is assessed at baseline and periodically for up to 5 years.
After completion of study therapy, patients are followed periodically for at least 5 years
or until disease recurrence.
PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Squamous cell or nonsquamous cell histology
- Stage IB or II disease
- Tumor amenable to curative surgical resection
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after
completion of study therapy
- Medical fitness must be adequate for radical NSCLC surgery
- WBC ≥ 4,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- ALT and AST ≤ 2.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL
- No second primary malignancy
- No active uncontrolled infection
- No concurrent serious disorder that would compromise patient safety or tolerance of
study therapy
- No significant neurological or mental disorder
- No myocardial infarction within the past 6 months
- No symptomatic heart disease, including any of the following:
- Unstable angina
- Congestive heart failure
- Uncontrolled arrhythmia
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or anticancer therapy
- No prior surgery for NSCLC
- No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response
modifier)
- No major surgery (other than biopsy) within the past 2 weeks
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time to recurrence
Safety Issue:
No
Principal Investigator
Heungtae T. Kim, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Center, Korea
Authority:
Unspecified
Study ID:
CDR0000516823
NCT ID:
NCT00398385
Start Date:
May 2005
Completion Date:
Related Keywords:
- Lung Cancer
- squamous cell lung cancer
- adenocarcinoma of the lung
- adenosquamous cell lung cancer
- bronchoalveolar cell lung cancer
- large cell lung cancer
- stage IB non-small cell lung cancer
- stage IIA non-small cell lung cancer
- stage IIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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