None listed
Conditions
Brief summary
RATIONALE: Steroid therapy, such as dexamethasone, may reduce swelling, pain, and other symptoms of inflammation and may be effective in treating some of the problems caused by cancer and cancer treatment. Supportive care improves the quality of life of patients with a serious or life-threatening disease, and prevents or treats symptoms of cancer, side effects of treatment, and other problems related to cancer or its treatment. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether dexamethasone given together with supportive care is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying dexamethasone and supportive care to see how well it works with or without whole-brain radiation therapy in improving the quality of life of patients with non-small cell lung cancer that has spread to the brain and cannot be removed by surgery.
Interventions
Experimental Arm: Optimal Supportive Care (including dexamethasone) alone
Optimal supportive care (OSC) includes 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.
Dexamethasone: the dexa
Experimental Arm: Optimal Supportive Care (including dexamethasone) alone Optimal supportive care (OSC) includes 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. Dexamethasone: the dexamethasone dose for patients in both arms of the study should be titrated down to the minimum required to control the patient’s symptoms of brain metastases. The timing and rate of dose reduction should be appropriate to the individual patient and be under the control of the treating clinician. Administration is orally. The duration also depends on individual patients requirments. OSC in both arms will continue as required by the patient until death.
Sponsors
Tanya Holt
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically or cytologically proven primary Non Small Cell Lung Cancer- Computed Tomography(CT)/Magnetic Resonance Imaging (MRI) confirming brain metastases - Inoperable brain metastases as assessed by a lung cancer Multi-Disciplinary Team (MDT) or patients for whom surgery is deemed inappropriate- Clinician and patient uncertain of the role of WBRT- Patient able and willing to respond to questions in a weekly telephone assessment- Patient able and willing to give informed consent- Baseline Patient Assessment Form completed.
Exclusion criteria
Clinician and / or patient certain that WBRT will be of benefit- Clinician and / or patient certain that WBRT will not be of benefit - Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons- Epidermal Growth Factor Receptor (EGFR) inhibitors within one week prior to randomisation- Chemotherapy (last cycle) within one month prior to randomisation- Previous radiotherapy to the brain- Surgery for brain metastases within one month prior to randomisation
Outcome results
None listed