Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer.

OBJECTIVES:

• Determine whether prophylactic cranial irradiation improves survival after effective locoregional/systemic therapy in patients with stage IIIA or IIIB non-small cell lung cancer.
• Determine the neuropsychologic impact of this therapy in these patients.
• Assess quality of life of patients receiving this therapy.
• Determine the impact of this therapy on the incidence of CNS metastases in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IIIA vs IIIB), histology (non-squamous cell vs squamous cell), and prior surgery (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks.
• Arm II: Patients undergo observation.

Patients are followed 3 months during the first year, every 6 months for 2-3 years and then annually thereafter. Quality of life is assessed at baseline and at months 6, 12, 24, 36, and 48.

PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for this study within 36 months.

DISEASE CHARACTERISTICS:

• Diagnosis of stage IIIA or IIIB non-small cell lung cancer

  • Complete response, partial response, or stable disease after definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy (chemotherapy alone does not constitute definitive therapy))

    • No more than 16 weeks since prior therapy

• No progressive disease

• No extracranial distant metastatic disease

• No suspicion of CNS metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No other malignancy within the past 3 years except nonmelanoma skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anticancer biologic therapy

Chemotherapy

• See Disease Characteristics
• No concurrent anticancer cytotoxic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior cranial irradiation

Surgery

• See Disease Characteristics

Other

• Recovered from all prior therapies
• No concurrent enrollment on any other phase III study that has progression-free, disease-free, or overall survival as an endpoint