Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00016211

EORTC-22993-08993

EORTC-RA-22993

EORTC-LCG-08993

Details and patient eligibility

About

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

Full description

OBJECTIVES:

• Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy.
• Compare the quality of life and survival of these patients.
• Determine the toxicity of this regimen in these patients.
• Determine the health economics associated with this study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days.
• Arm II: Patients receive no further therapy after completion of prior chemotherapy.

Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.

Enrollment: 287 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Cytologically or histologically confirmed small cell lung cancer

  • Documented extensive disease before the initiation of chemotherapy

• Responsive disease after 4 to 6 courses of initial chemotherapy

  • No more than 5 weeks since completion of prior chemotherapy

• No brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix
• No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• No concurrent corticosteroids

Radiotherapy:

• No prior radiotherapy to the brain
• No prior radiotherapy to the head and neck

Surgery:

• Not specified