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Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398385
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 10, 2006
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before surgery is more effective than giving it after surgery in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
Study Start Date : May 2005
Estimated Primary Completion Date : April 2010

Primary Outcome Measures :
  1. Time to recurrence

Secondary Outcome Measures :
  1. Overall survival
  2. Toxicity
  3. Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0
  4. Complete resection rate
  5. Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years
  6. Patient population most at risk for disease recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 modifier)
  • No major surgery (other than biopsy) within the past 2 weeks
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398385

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Korea, Republic of
National Cancer Center - Korea Recruiting
Goyang, Korea, Republic of, 410-769
Contact: Heungtae T. Kim, MD, PhD    82-31-920-1622   
Sponsors and Collaborators
National Cancer Center, Korea
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Study Chair: Heungtae T. Kim, MD, PhD National Cancer Center, Korea

Layout table for additonal information Identifier: NCT00398385     History of Changes
Other Study ID Numbers: NCC-NCCCTS-05-122
CDR0000516823 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs