Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403065
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2006-11-21
Brief Title:
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
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 eg 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 patients disease and treatment on the caregivers quality of life
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL At least 1000 patients will be accrued for this study
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 eg 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 patients disease and treatment on the caregivers quality of life
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL At least 1000 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TROG 0702 | None | None | None |
| MRC-LU24-QUARTZ | None | None | None |
| EU-20653 | None | None | None |
| ISRCTN3826061 | None | None | None |