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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00398385
First received: November 9, 2006
Last updated: August 9, 2013
Last verified: April 2008
  Purpose

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 Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Complete resection rate [ Designated as safety issue: No ]
  • Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years [ Designated as safety issue: No ]
  • Patient population most at risk for disease recurrence [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: May 2005
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398385

Locations
Korea, Republic of
National Cancer Center - Korea Recruiting
Goyang, Korea, Republic of, 410-769
Contact: Heungtae T. Kim, MD, PhD    82-31-920-1622    htkim@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Study Chair: Heungtae T. Kim, MD, PhD National Cancer Center, Korea
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00398385     History of Changes
Other Study ID Numbers: NCC-NCCCTS-05-122, CDR0000516823
Study First Received: November 9, 2006
Last Updated: August 9, 2013
Health Authority: Unspecified

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014