Cisplatin, Vinorelbine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving combination chemotherapy followed by radiation therapy is more effective than giving combination chemotherapy together with radiation therapy followed by more chemotherapy in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Cisplatin; Vinblastine; Vinorelbine

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