Cisplatin, Vinorelbine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery (SOCCAR)
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Clatterbridge Centre for Oncology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Sequential arm (SEQ)
Experimental arm (CON)
Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).
Concurrent chemo-radiotherapy [55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20] followed by two cycles of cisplatinum/vinorelbine.