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WithdrawnNCT00329472Updated Aug 27, 2010

Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer

A Phase 3 interventional study of gemcitabine, cisplatin in Carcinoma, Non-Small-Cell Lung, sponsored by Samsung Medical Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-27.

Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment

Why this study was withdrawn
poor enrollment
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This study is randomized phase III trial designed to assess whether (preoperative) neoadjuvant chemotherapy followed by surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (experimental treatment) improves 3-year disease-free survival, compared to surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (standard treatment) in stage IB, IIA, IIB and T3N1 non-small cell lung cancer

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Conditions studied

  • Carcinoma, Non-Small-Cell Lung
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically proven NSCLC patients
  • All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest CT and PET-CT
  • 18 year of ages or older
  • ECOG performance status 0-1
  • Uni-dimensionally measurable lesion by RECIST criteria
  • No prior chemotherapy or radiotherapy for NSCLC
  • Pre-operative FEV1 ≥ 2.0 L evaluated within 28 days
  • Adequate bone marrow function: Hb > 9.0 g/dL, WBC ≥ 4,000/μL, platelet count ≥ 100,000/μL
  • Adequate liver and renal function: Total bilirubin \< 2 x ULN, AST/ALT \< 3 x ULN, serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Superior sulcus tumor
  • Prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer at least 5 years
  • Uncontrolled systemic illness such as DM, CHF, unstable angina or arrhythmia
  • Recent myocardial infarction within 6 months
  • Patients with post-obstructive pneumonia or serious infection
  • Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method.)
  • Patients with psychological problem
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Gem/Cis

    neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 \& cisplatin 70mg/m2 , 2 cycles

    Drug: gemcitabine, cisplatin

  • No intervention
    no neoadjuvant chemotherapy

Interventions

  • Druggemcitabine, cisplatin
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What researchers measure

Primary outcomes

  1. 3-year disease-free survival

Secondary outcomes

  1. overall survival

  2. pattern of relapse

  3. quality of life

  4. operative mortality and toxicity

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00329472
Lead sponsor
Samsung Medical Center
First posted
May 24, 2006
Start date
Apr 2006
Primary completion
Jul 2010 (estimated)
Completion
Jul 2010 (estimated)
Last update
Aug 27, 2010

Study contacts

Keunchil Park, M.D.
principal investigator · Samsung Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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