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

This study is currently recruiting participants.

Verified by Samsung Medical Center, May 2006

Sponsors and Collaborators:	Samsung Medical Center Eli Lilly and Company
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00329472

Purpose

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

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: gemcitabine, cisplatin	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

3-year disease-free survival

Secondary Outcome Measures:

overall survival
pattern of relapse
quality of life
operative mortality and toxicity

Estimated Enrollment:	500
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329472

Contacts

Contact: Keunchil Park, M.D.

82-2-3410-3459

kpark@smc.samsung.co.kr

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Eli Lilly and Company

Investigators

Principal Investigator:

Keunchil Park, M.D.

Samsung Medical Center

More Information

Study ID Numbers:	2004-09-027
Study First Received:	May 22, 2006
Last Updated:	May 23, 2006
ClinicalTrials.gov Identifier:	NCT00329472
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009