Status:
COMPLETED
Cisplatin, Vinorelbine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
University College, London
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radia...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by radical...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC)
- Patients with stage IIIB disease must not have a pleural effusion that is cytologically proven to be malignant
- Inoperable disease
- Disease must be able to be encompassed within a radical radiotherapy treatment volume
- PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- Life expectancy \> 3 months
- Patient considered able to tolerate platinum-based chemotherapy and radical radiotherapy
- Glomerular filtration rate ≥ 60 mL/min
- WBC \> 3,000/mm³
- Absolute neutrophil count \> 1,500/mm³
- Hemoglobin \> 10.0 g/dL
- Patients with hemoglobin between 10 and 12 g/dL at randomization require a blood transfusion to ensure hemoglobin \> 12 g/dL before starting radiotherapy
- Platelet count \> 100,000/mm³
- FEV\_1 ≥ 1.0 L or DLCO (transfer factor) ≥ 50% of predicted
- Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
- Gamma-glutamyl-transferase \< 1.5 times ULN
- Transaminases ≤ 1.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease)
- Not pregnant or nursing
- Fertile patients must agree to use effective contraception
- Negative pregnancy test
- No other previous or current malignant disease likely to interfere with protocol treatment or comparisons
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or investigational agents
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00309972
Start Date
December 1 2005
End Date
February 1 2012
Last Update
December 3 2014
Active Locations (1)
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1
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY