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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Status: Withdrawn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

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

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

Eligibility

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

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

Locations and Contacts

Additional Information

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

Page last updated: August 23, 2015

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