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A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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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



- 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


- 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


- 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


- 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


- No prior chemotherapy or anticancer therapy

- No prior surgery for NSCLC

- No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response

- No major surgery (other than biopsy) within the past 2 weeks

- No other concurrent anticancer therapy

- No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Time to recurrence

Safety Issue:


Principal Investigator

Heungtae T. Kim, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center, Korea



Study ID:




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