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

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: gemcitabine, cisplatin (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Keunchil Park, M.D., Principal Investigator, Affiliation: Samsung Medical Center


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

Clinical Details

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)

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

Primary outcome: 3-year disease-free survival

Secondary outcome:

overall survival

pattern of relapse

quality of life

operative mortality and toxicity


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Histologically or cytologically proven NSCLC patients

- All patients must have: Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest


- 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 ≥


- 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

Locations and Contacts

Additional Information

Starting date: April 2006
Last updated: August 26, 2010

Page last updated: August 23, 2015

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