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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Patient-assessed quality adjusted life years []
Secondary Outcome Measures
- Overall survival []
- Karnofsky performance status []
- Patient symptoms []
- Assessment and measurement of caregiver concerns []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically or cytologically confirmed primary non-small cell lung cancer
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Must have brain metastases confirmed by CT scan or MRI
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Unresectable disease OR surgery is deemed inappropriate
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The benefit or lack of benefit of whole-brain radiotherapy (WBRT) cannot be clearly defined
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Any known certainty of the benefit or lack of benefit of WBRT is not allowed
PATIENT CHARACTERISTICS:
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No prior or concurrent uncontrolled illness that could preclude study treatment or comparisons
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Must be able to respond to weekly telephone assessment questions
PRIOR CONCURRENT THERAPY:
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More than 1 week since prior epidermal growth factor receptor inhibitors
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More than 1 month since prior chemotherapy
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More than 1 month since prior surgery for brain metastases
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No prior radiotherapy to the brain
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wansbeck General Hospital | Ashington | England | United Kingdom | NE63 9JJ |
| 2 | Sussex Cancer Centre at Royal Sussex County Hospital | Brighton | England | United Kingdom | BN2 5BE |
| 3 | Bristol Haematology and Oncology Centre | Bristol | England | United Kingdom | BS2 8ED |
| 4 | Addenbrooke's Hospital | Cambridge | England | United Kingdom | CB2 2QQ |
| 5 | Papworth Hospital | Cambridge | England | United Kingdom | CB3 8RE |
| 6 | Cumberland Infirmary | Carlisle | England | United Kingdom | CA2 7HY |
| 7 | Gloucestershire Oncology Centre at Cheltenham General Hospital | Cheltenham | England | United Kingdom | GL53 7AN |
| 8 | Saint Richards Hospital | Chichester | England | United Kingdom | P019 4SE |
| 9 | Castle Hill Hospital | Cottingham | England | United Kingdom | HU16 5JQ |
| 10 | Walsgrave Hospital | Coventry | England | United Kingdom | CV2 2DX |
| 11 | Darlington Memorial | Darlington | England | United Kingdom | DL3 6HX |
| 12 | Derbyshire Royal Infirmary | Derby | England | United Kingdom | DE1 2QY |
| 13 | Dorset County Hospital | Dorchester | England | United Kingdom | DT1 2JY |
| 14 | University Hospital of North Durham | Durham | England | United Kingdom | DH1 5TW |
| 15 | Bishop Auckland Hospital | Durham | England | United Kingdom | |
| 16 | Royal Devon and Exeter Hospital | Exeter | England | United Kingdom | EX2 5DW |
| 17 | Queen Elizabeth Hospital | Gateshead | England | United Kingdom | NE9 6SX |
| 18 | Diana Princess of Wales Hospital | Grimsby | England | United Kingdom | DN33 2BA |
| 19 | Hereford Hospitals | Hereford | England | United Kingdom | HR1 2ER |
| 20 | Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | United Kingdom | HD3 3EA |
| 21 | Princess Royal Hospital at Hull and East Yorkshire NHS Trust | Hull | England | United Kingdom | HU8 9HE |
| 22 | Ipswich Hospital | Ipswich | England | United Kingdom | IP4 5PD |
| 23 | Queen Elizabeth Hospital | King's Lynn | England | United Kingdom | PE30 4ET |
| 24 | Cookridge Hospital | Leeds | England | United Kingdom | LS16 6QB |
| 25 | Aintree University Hospital | Liverpool | England | United Kingdom | L9 7AL |
| 26 | Whipps Cross Hospital | London | England | United Kingdom | E11 1NR |
| 27 | Newham University Hospital | London | England | United Kingdom | E13 85L |
| 28 | Homerton University Hospital | London | England | United Kingdom | E9 6SR |
| 29 | Saint Bartholomew's Hospital | London | England | United Kingdom | EC1A 7BE |
| 30 | Guy's Hospital | London | England | United Kingdom | SE1 9RT |
| 31 | St. Mary's Hospital | London | England | United Kingdom | W2 1NY |
| 32 | UCL Cancer Institute | London | England | United Kingdom | WC1E 6DD |
| 33 | Christie Hospital | Manchester | England | United Kingdom | M20 4BX |
| 34 | Clatterbridge Centre for Oncology | Merseyside | England | United Kingdom | CH63 4JY |
| 35 | James Cook University Hospital | Middlesbrough | England | United Kingdom | TS4 3BW |
| 36 | Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle-Upon-Tyne | England | United Kingdom | NE4 6BE |
| 37 | North Tyneside Hospital | North Shields | England | United Kingdom | NE29 8NH |
| 38 | Friarage Hospital | North Yorkshire | England | United Kingdom | DL6 1JG |
| 39 | Northampton General Hospital | Northampton | England | United Kingdom | NN1 5BD |
| 40 | Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | United Kingdom | HA6 2RN |
| 41 | Nottingham City Hospital | Nottingham | England | United Kingdom | NG5 1PB |
| 42 | George Eliot Hospital | Nuneaton | England | United Kingdom | CV10 7DJ |
| 43 | Dorset Cancer Centre | Poole Dorset | England | United Kingdom | BH15 2JB |
| 44 | Portsmouth Oncology Centre at Saint Mary's Hospital | Portsmouth Hants | England | United Kingdom | PO3 6AD |
| 45 | Whiston Hospital | Prescot Merseyside | England | United Kingdom | L35 5DR |
| 46 | Berkshire Cancer Centre at Royal Berkshire Hospital | Reading | England | United Kingdom | RG1 5AN |
| 47 | Alexandra Healthcare NHS | Redditch, Worcestershire | England | United Kingdom | B98 7UB |
| 48 | South Tyneside District Hospital | South Shields | England | United Kingdom | NE34 0PL |
| 49 | Southampton General Hospital | Southampton | England | United Kingdom | SO16 6YD |
| 50 | Southport and Formby District General Hospital | Southport | England | United Kingdom | PR8 6PN |
| 51 | University Hospital of North Tees | Stockton-On-Tees | England | United Kingdom | TS19 8PE |
| 52 | Taunton and Somerset Hospital | Taunton | England | United Kingdom | TA1 5DA |
| 53 | Torbay Hospital | Torquay | England | United Kingdom | TQ2 7AA |
| 54 | Royal Cornwall Hospital | Truro | England | United Kingdom | TR1 3LJ |
| 55 | Walsall Manor Hospital | Walsall | England | United Kingdom | WS2 9PS |
| 56 | South Warwickshire Hospital | Warwick, Warwickshire | England | United Kingdom | CV34 5BJ |
| 57 | New Cross Hospital | Wolverhampton | England | United Kingdom | WV10 0QP |
| 58 | Worcester Royal Hospital | Worcester | England | United Kingdom | WR5 1DD |
| 59 | Cancer Care Centre at York Hospital | York | England | United Kingdom | Y031 8HE |
| 60 | Centre for Cancer Research and Cell Biology at Queen's University Belfast | Belfast | Northern Ireland | United Kingdom | BT9 7AB |
| 61 | Aberdeen Royal Infirmary | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
| 62 | Ninewells Hospital | Dundee | Scotland | United Kingdom | DD1 9SY |
| 63 | Hairmyres Hospital | East Kilbride | Scotland | United Kingdom | G75 8RG |
| 64 | Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland | United Kingdom | EH4 2XU |
| 65 | Beatson West of Scotland Cancer Centre | Glasgow | Scotland | United Kingdom | G12 0YN |
| 66 | Raigmore Hospital | Inverness | Scotland | United Kingdom | 1V2 3UJ |
| 67 | Crosshouse Hospital | Kilmarnock | Scotland | United Kingdom | KA2 OBE |
| 68 | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | United Kingdom | CF14 2TL |
| 69 | Llandough Hospital | Llandough | Wales | United Kingdom | CF64 2XX |
| 70 | Glan Clwyd Hospital | Rhyl, Denbighshire | Wales | United Kingdom | LL 18 5UJ |
Sponsors and Collaborators
- Medical Research Council
Investigators
- Study Chair: Paula Mulvenna, Northern Centre for Cancer Treatment at Newcastle General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000517194
- MRC-LU24-QUARTZ
- EU-20653
- ISRCTN3826061
- TROG 07.02