OBJECTIVES:
Primary
* Compare the efficacy of dexamethasone with vs without whole-brain radiotherapy in combination with optimal supportive care, in terms of patient assessed quality adjusted life years, in patients with inoperable brain metastases secondary to non-small cell lung cancer.
Secondary
* Compare the overall survival of patients treated with these regimens.
* Assess the Karnofsky performance status of patients treated with these regimens.
* Assess the symptoms of patients treated with these regimens.
* Determine the feasibility of assessing and measuring caregiver concerns.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I (experimental): Patients receive dexamethasone\*. Patients receive optimal supportive care (OSC) including a prescription of a proton pump inhibitor while on dexamethasone, parallel nursing support, access to additional specialists (e.g., pain-relief service, palliative care team, medical social worker, or physiotherapist), and open access to follow-up in a specialist clinic. OSC may also include analgesics, bronchodilators, and other supportive treatment as needed.
* Arm II (control): Patients receive dexamethasone\* and OSC as in arm I. Patients also undergo whole-brain radiotherapy once daily for 5 days in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients who are receiving prednisolone at randomization need to convert to dexamethasone immediately.
All patients undergo telephone assessment, including quality of life assessment, once a week for 12 weeks and then once every 4 weeks thereafter. Consenting caregivers complete questionnaire over the telephone once a week to assess the impact of the patient's disease and treatment on the caregiver's quality of life.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: At least 1,000 patients will be accrued for this study.
