Status:
UNKNOWN
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
Yonsei University
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from divid...
Detailed Description
OBJECTIVES: Primary * To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lu...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA (N2) or IIIB disease
- Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter
- No stage IIIB disease with malignant pleural effusion or superior sulcus tumor
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
- Unresectable disease
- No known brain metastasis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 3 months
- ANC ≥ 1,500/mm³
- Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)
- Platelet count ≥ 100,000/mm³
- Creatinine \< 1.5 mg/dL
- Total bilirubin \< 2 times upper limit of normal (ULN)
- Transaminases \< 3 times ULN
- Patient compliance and geographic proximity that allow adequate follow up
- No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
- No history of significant neurological or mental disorder, including seizures or dementia
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- No active cardiac disease not controlled by therapy
- No myocardial infarction within the past 12 months
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for NSCLC
- No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00616785
Start Date
June 1 2007
Last Update
February 9 2009
Active Locations (1)
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1
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea, 120-752