Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Medical Research Council
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
