Trial Information

Quality of Life After Radiotherapy & Steroids. A Phase III Multi-Centre Randomised Controlled Trial to Assess Whether Optimal Supportive Care Alone (Including Dexamathasone) is As Effective as Optimal Supportive Care (Including Dexamethasone ) Plus Whole Brain Radiotherapy in the Treatment of Patients With Inoperable Brain Metastases From Non-Small Cell Lung Cancer

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.