Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

• Compare the overall survival of patients with stage I-III non-small cell lung cancer treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated radiotherapy (CHART) vs CHART alone.

Secondary

• Compare the response, progression-free survival, and quality of life of patients treated with these regimens.
• Compare the toxic effect of these regimens in these patients.
• Compare the cost effectiveness of these regimens in these patients.
• Compare the local and distant control in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo continuous hyperfractionated accelerated radiotherapy (CHART) 3 times a day for 12 consecutive days.
• Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks later, patients undergo CHART as in arm I.

Quality of life is assessed periodically.

After completion of study treatment, patients are evaluated periodically for at least 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I-III non-small cell lung cancer

• Inoperable or patient refuses surgery
• Disease can be encompassed within the radical radiotherapy treatment volume

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin < 1.5 times upper limit of normal

Renal

• Glomerular filtration rate > 60 mL/min

Cardiovascular

• No uncontrolled arterial hypertension
• No ischemic heart disease

Pulmonary

• FEV_1 > 50% of predicted OR
• DLCO > 50% of predicted

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior or current malignancy that would preclude study treatment
• Medically stable
• No unstable diabetes
• No infection
• No hypercalcemia

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy