NCT00398385

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

August 12, 2013

Status Verified

April 1, 2008

Enrollment Period

4.9 years

First QC Date

November 9, 2006

Last Update Submit

August 9, 2013

Conditions

Lung Cancer

Keywords

squamous cell lung canceradenocarcinoma of the lungadenosquamous cell lung cancerbronchoalveolar cell lung cancerlarge cell lung cancerstage IB non-small cell lung cancerstage IIA non-small cell lung cancerstage IIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Time to recurrence

Secondary Outcomes (6)

  • Overall survival

  • Toxicity

  • Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0

  • Complete resection rate

  • Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years

  • +1 more secondary outcomes

Interventions

cisplatinDRUG
gemcitabine hydrochlorideDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center - Korea

Goyang, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-AlveolarCarcinoma, Non-Small-Cell Lung

Interventions

CisplatinGemcitabineChemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Heungtae T. Kim, MD, PhD

    National Cancer Center, Korea

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 10, 2006

Study Start

May 1, 2005

Primary Completion

April 1, 2010

Last Updated

August 12, 2013

Record last verified: 2008-04

Locations

KR(1)