Lung CancerPhase 3NCT00403065
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
A Phase 3 study testing dexamethasone, quality-of-life assessment and radiation therapy in people with Lung Cancer and Metastatic Cancer, run by Medical Research Council at 70 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Metastatic Cancer
- What is being tested?
- dexamethasone, quality-of-life assessment and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 70 sitesUnited Kingdom
- Study dates
- Oct 2006to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary non-small cell lung cancer
- Must have brain metastases confirmed by CT scan or MRI
- Unresectable disease OR surgery is deemed inappropriate
- The benefit or lack of benefit of whole-brain radiotherapy (WBRT) cannot be clearly defined
- Any known certainty of the benefit or lack of benefit of WBRT is not allowed
PATIENT CHARACTERISTICS:
- No prior or concurrent uncontrolled illness that could preclude study treatment or comparisons
- Must be able to respond to weekly telephone assessment questions
PRIOR CONCURRENT THERAPY:
- More than 1 week since prior epidermal growth factor receptor inhibitors
- More than 1 month since prior chemotherapy
- More than 1 month since prior surgery for brain metastases
- No prior radiotherapy to the brain
Trial locations and contacts
70 sites in 1 country.
70 sites in 1 country
United Kingdom70 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Wansbeck General Hospital
Ashington, England, NE63 9JJ
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7AB
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Papworth Hospital
Cambridge, England, CB3 8RE
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Cumberland Infirmary
Carlisle, England, CA2 7HY
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Saint Richards Hospital
Chichester, England, P019 4SE
Castle Hill Hospital
Cottingham, England, HU16 5JQ
Walsgrave Hospital
Coventry, England, CV2 2DX
Darlington Memorial
Darlington, England, DL3 6HX
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Dorset County Hospital
Dorchester, England, DT1 2JY
Ninewells Hospital
Dundee, Scotland, DD1 9SY
University Hospital of North Durham
Durham, England, DH1 5TW
Bishop Auckland Hospital
Durham, England
Hairmyres Hospital
East Kilbride, Scotland, G75 8RG
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
Hereford Hospitals
Hereford, England, HR1 2ER
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
Ipswich Hospital
Ipswich, England, IP4 5PD
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE
Queen Elizabeth Hospital
Kings Lynn, England, PE30 4ET
Cookridge Hospital
Leeds, England, LS16 6QB
Aintree University Hospital
Liverpool, England, L9 7AL
Llandough Hospital
Llandough, Wales, CF64 2XX
Whipps Cross Hospital
London, England, E11 1NR
Newham University Hospital
London, England, E13 85L
Homerton University Hospital
London, England, E9 6SR
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Guy's Hospital
London, England, SE1 9RT
St. Mary's Hospital
London, England, W2 1NY
UCL Cancer Institute
London, England, WC1E 6DD
Christie Hospital
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
North Tyneside Hospital
North Shields, England, NE29 8NH
Friarage Hospital
North Yorks, England, DL6 1JG
Northampton General Hospital
Northampton, England, NN1 5BD
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital
Nottingham, England, NG5 1PB
George Eliot Hospital
Nuneaton, England, CV10 7DJ
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD
Whiston Hospital
Prescot Merseyside, England, L35 5DR
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN
Alexandra Healthcare NHS
Redditch, Worcestershire, England, B98 7UB
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
South Tyneside District Hospital
South Shields, England, NE34 0PL
Southampton General Hospital
Southampton, England, SO16 6YD
Southport and Formby District General Hospital
Southport, England, PR8 6PN
University Hospital of North Tees
Stockton-on-Tees, England, TS19 8PE
Taunton and Somerset Hospital
Taunton, England, TA1 5DA
Torbay Hospital
Torquay, England, TQ2 7AA
Royal Cornwall Hospital
Truro, England, TR1 3LJ
Walsall Manor Hospital
Walsall, England, WS2 9PS
South Warwickshire Hospital
Warwick, Warwickshire, England, CV34 5BJ
New Cross Hospital
Wolverhampton, England, WV10 0QP
Worcester Royal Hospital
Worcester, England, WR5 1DD
Cancer Care Centre at York Hospital
York, England, Y031 8HE
About this study
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
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.
Read the 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 (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.
- Conditions
- Lung Cancer, Metastatic Cancer
- Being tested
- dexamethasone, quality-of-life assessment, radiation therapy
- Keywords
- recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, tumors metastatic to brain
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
quality-of-life assessmentProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-assessed quality adjusted life years
Secondary outcomes (4)
Overall survival
Karnofsky performance status
Patient symptoms
Assessment and measurement of caregiver concerns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startOct 2006
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Paula Mulvenna, Study chair, Northern Centre for Cancer Treatment at Newcastle General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403065
- Sponsor's protocol ID
- CDR0000517194
- Other IDs
- MRC-LU24-QUARTZ, EU-20653, ISRCTN3826061, TROG 07.02
- Status last verified
- Jan 2007
- First submitted
- 21 Nov 2006
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00403065
- Acronym / sponsor ID
- CDR0000517194
- Conditions
- Lung Cancer, Metastatic Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, tumors metastatic to brain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Oct 2006
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Patient-assessed quality adjusted life years
4 secondary outcomes
Overall survival
Karnofsky performance status
Patient symptoms
Assessment and measurement of caregiver concerns
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Mulvenna study chair
Northern Centre for Cancer Treatment at Newcastle General Hospital
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone, quality-of-life assessment and radiation therapy in people with Lung Cancer and Metastatic Cancer, run by Medical Research Council at 70 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-assessed quality adjusted life years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.