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

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)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329472

Enrollment

Registered

2006-05-24

Start date

2006-04-30

Completion date

2010-07-31

Last updated

2010-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief 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

Interventions

DRUGgemcitabine, cisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
3-year disease-free survival	—

Secondary

Measure	Time frame
overall survival	—
pattern of relapse	—
quality of life	—
operative mortality and toxicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026