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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00329472
• Other study ID #: 2004-09-027
• Status: Withdrawn
• Phase: Phase 3
• First received: May 22, 2006
• Last updated: August 26, 2010
• Start date: April 2006
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• gemcitabine, cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival
Secondary	overall survival
Secondary	pattern of relapse
Secondary	quality of life
Secondary	operative mortality and toxicity