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
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
5 other identifiers
interventional
1,000
1 country
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lung-cancer
Started Oct 2006
Typical duration for phase_3 lung-cancer
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 21, 2006
CompletedFirst Posted
Study publicly available on registry
November 23, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedAugust 26, 2013
January 1, 2007
November 21, 2006
August 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient-assessed quality adjusted life years
Secondary Outcomes (4)
Overall survival
Karnofsky performance status
Patient symptoms
Assessment and measurement of caregiver concerns
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (70)
Wansbeck General Hospital
Ashington, England, NE63 9JJ, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ, United Kingdom
Papworth Hospital
Cambridge, England, CB3 8RE, United Kingdom
Cumberland Infirmary
Carlisle, England, CA2 7HY, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN, United Kingdom
Saint Richards Hospital
Chichester, England, P019 4SE, United Kingdom
Castle Hill Hospital
Cottingham, England, HU16 5JQ, United Kingdom
Walsgrave Hospital
Coventry, England, CV2 2DX, United Kingdom
Darlington Memorial
Darlington, England, DL3 6HX, United Kingdom
Derbyshire Royal Infirmary
Derby, England, DE1 2QY, United Kingdom
Dorset County Hospital
Dorchester, England, DT1 2JY, United Kingdom
University Hospital of North Durham
Durham, England, DH1 5TW, United Kingdom
Bishop Auckland Hospital
Durham, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA, United Kingdom
Hereford Hospitals
Hereford, England, HR1 2ER, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE, United Kingdom
Ipswich Hospital
Ipswich, England, IP4 5PD, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, England, PE30 4ET, United Kingdom
Cookridge Hospital
Leeds, England, LS16 6QB, United Kingdom
Aintree University Hospital
Liverpool, England, L9 7AL, United Kingdom
Whipps Cross Hospital
London, England, E11 1NR, United Kingdom
Newham University Hospital
London, England, E13 85L, United Kingdom
Homerton University Hospital
London, England, E9 6SR, United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE, United Kingdom
Guy's Hospital
London, England, SE1 9RT, United Kingdom
St. Mary's Hospital
London, England, W2 1NY, United Kingdom
UCL Cancer Institute
London, England, WC1E 6DD, United Kingdom
Christie Hospital
Manchester, England, M20 4BX, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY, United Kingdom
James Cook University Hospital
Middlesbrough, England, TS4 3BW, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE, United Kingdom
North Tyneside Hospital
North Shields, England, NE29 8NH, United Kingdom
Friarage Hospital
North Yorks, England, DL6 1JG, United Kingdom
Northampton General Hospital
Northampton, England, NN1 5BD, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN, United Kingdom
Nottingham City Hospital
Nottingham, England, NG5 1PB, United Kingdom
George Eliot Hospital
Nuneaton, England, CV10 7DJ, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD, United Kingdom
Whiston Hospital
Prescot Merseyside, England, L35 5DR, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN, United Kingdom
Alexandra Healthcare NHS
Redditch, Worcestershire, England, B98 7UB, United Kingdom
South Tyneside District Hospital
South Shields, England, NE34 0PL, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
Southport and Formby District General Hospital
Southport, England, PR8 6PN, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, England, TS19 8PE, United Kingdom
Taunton and Somerset Hospital
Taunton, England, TA1 5DA, United Kingdom
Torbay Hospital
Torquay, England, TQ2 7AA, United Kingdom
Royal Cornwall Hospital
Truro, England, TR1 3LJ, United Kingdom
Walsall Manor Hospital
Walsall, England, WS2 9PS, United Kingdom
South Warwickshire Hospital
Warwick, Warwickshire, England, CV34 5BJ, United Kingdom
New Cross Hospital
Wolverhampton, England, WV10 0QP, United Kingdom
Worcester Royal Hospital
Worcester, England, WR5 1DD, United Kingdom
Cancer Care Centre at York Hospital
York, England, Y031 8HE, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7AB, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Ninewells Hospital
Dundee, Scotland, DD1 9SY, United Kingdom
Hairmyres Hospital
East Kilbride, Scotland, G75 8RG, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN, United Kingdom
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ, United Kingdom
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
Llandough Hospital
Llandough, Wales, CF64 2XX, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paula Mulvenna
Northern Centre for Cancer Treatment at Newcastle General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 21, 2006
First Posted
November 23, 2006
Study Start
October 1, 2006
Study Completion
March 1, 2013
Last Updated
August 26, 2013
Record last verified: 2007-01