Dexamethasone and Supportive Care With or Without Whole-Brain Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer That Has Spread to the Brain and Cannot Be Removed By Surgery

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.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary non-small cell lung cancer
• Must have brain metastases confirmed by CT scan or MRI

• Unresectable disease OR surgery is deemed inappropriate
• The benefit or lack of benefit of whole-brain radiotherapy (WBRT) cannot be clearly defined

• Any known certainty of the benefit or lack of benefit of WBRT is not allowed

PATIENT CHARACTERISTICS:

• No prior or concurrent uncontrolled illness that could preclude study treatment or comparisons
• Must be able to respond to weekly telephone assessment questions

PRIOR CONCURRENT THERAPY:

• More than 1 week since prior epidermal growth factor receptor inhibitors
• More than 1 month since prior chemotherapy
• More than 1 month since prior surgery for brain metastases
• No prior radiotherapy to the brain