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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

Primary Purpose

Lung Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
dexamethasone
quality-of-life assessment
radiation therapy
Sponsored by
Medical Research Council
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, tumors metastatic to brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wansbeck General Hospital
  • Sussex Cancer Centre at Royal Sussex County Hospital
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital
  • Papworth Hospital
  • Cumberland Infirmary
  • Gloucestershire Oncology Centre at Cheltenham General Hospital
  • Saint Richards Hospital
  • Castle Hill Hospital
  • Walsgrave Hospital
  • Darlington Memorial
  • Derbyshire Royal Infirmary
  • Dorset County Hospital
  • University Hospital of North Durham
  • Bishop Auckland Hospital
  • Royal Devon and Exeter Hospital
  • Queen Elizabeth Hospital
  • Diana Princess of Wales Hospital
  • Hereford Hospitals
  • Huddersfield Royal Infirmary
  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
  • Ipswich Hospital
  • Queen Elizabeth Hospital
  • Cookridge Hospital
  • Aintree University Hospital
  • Whipps Cross Hospital
  • Newham University Hospital
  • Homerton University Hospital
  • Saint Bartholomew's Hospital
  • Guy's Hospital
  • St. Mary's Hospital
  • UCL Cancer Institute
  • Christie Hospital
  • Clatterbridge Centre for Oncology
  • James Cook University Hospital
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • North Tyneside Hospital
  • Friarage Hospital
  • Northampton General Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital
  • George Eliot Hospital
  • Dorset Cancer Centre
  • Portsmouth Oncology Centre at Saint Mary's Hospital
  • Whiston Hospital
  • Berkshire Cancer Centre at Royal Berkshire Hospital
  • Alexandra Healthcare NHS
  • South Tyneside District Hospital
  • Southampton General Hospital
  • Southport and Formby District General Hospital
  • University Hospital of North Tees
  • Taunton and Somerset Hospital
  • Torbay Hospital
  • Royal Cornwall Hospital
  • Walsall Manor Hospital
  • South Warwickshire Hospital
  • New Cross Hospital
  • Worcester Royal Hospital
  • Cancer Care Centre at York Hospital
  • Centre for Cancer Research and Cell Biology at Queen's University Belfast
  • Aberdeen Royal Infirmary
  • Ninewells Hospital
  • Hairmyres Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • Raigmore Hospital
  • Crosshouse Hospital
  • Velindre Cancer Center at Velindre Hospital
  • Llandough Hospital
  • Glan Clwyd Hospital

Outcomes

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

Full Information

First Posted
November 21, 2006
Last Updated
August 23, 2013
Sponsor
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00403065
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Cancer
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, tumors metastatic to brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Patient-assessed quality adjusted life years
Secondary Outcome Measure Information:
Title
Overall survival
Title
Karnofsky performance status
Title
Patient symptoms
Title
Assessment and measurement of caregiver concerns

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Mulvenna
Organizational Affiliation
Northern Centre for Cancer Treatment at Newcastle General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Wansbeck General Hospital
City
Ashington
State/Province
England
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB3 8RE
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
State/Province
England
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Gloucestershire Oncology Centre at Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
Chichester
State/Province
England
ZIP/Postal Code
P019 4SE
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
England
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Darlington Memorial
City
Darlington
State/Province
England
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
State/Province
England
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
University Hospital of North Durham
City
Durham
State/Province
England
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
Bishop Auckland Hospital
City
Durham
State/Province
England
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Diana Princess of Wales Hospital
City
Grimsby
State/Province
England
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
Hereford Hospitals
City
Hereford
State/Province
England
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
State/Province
England
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Newham University Hospital
City
London
State/Province
England
ZIP/Postal Code
E13 85L
Country
United Kingdom
Facility Name
Homerton University Hospital
City
London
State/Province
England
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
State/Province
England
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
London
State/Province
England
ZIP/Postal Code
WC1E 6DD
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
North Tyneside Hospital
City
North Shields
State/Province
England
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Friarage Hospital
City
North Yorkshire
State/Province
England
ZIP/Postal Code
DL6 1JG
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
George Eliot Hospital
City
Nuneaton
State/Province
England
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Dorset Cancer Centre
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Portsmouth Oncology Centre at Saint Mary's Hospital
City
Portsmouth Hants
State/Province
England
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot Merseyside
State/Province
England
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Berkshire Cancer Centre at Royal Berkshire Hospital
City
Reading
State/Province
England
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Alexandra Healthcare NHS
City
Redditch, Worcestershire
State/Province
England
ZIP/Postal Code
B98 7UB
Country
United Kingdom
Facility Name
South Tyneside District Hospital
City
South Shields
State/Province
England
ZIP/Postal Code
NE34 0PL
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Southport and Formby District General Hospital
City
Southport
State/Province
England
ZIP/Postal Code
PR8 6PN
Country
United Kingdom
Facility Name
University Hospital of North Tees
City
Stockton-On-Tees
State/Province
England
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
Taunton and Somerset Hospital
City
Taunton
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
State/Province
England
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
England
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
South Warwickshire Hospital
City
Warwick, Warwickshire
State/Province
England
ZIP/Postal Code
CV34 5BJ
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Worcester Royal Hospital
City
Worcester
State/Province
England
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
Cancer Care Centre at York Hospital
City
York
State/Province
England
ZIP/Postal Code
Y031 8HE
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Queen's University Belfast
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Hairmyres Hospital
City
East Kilbride
State/Province
Scotland
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Crosshouse Hospital
City
Kilmarnock
State/Province
Scotland
ZIP/Postal Code
KA2 OBE
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Llandough Hospital
City
Llandough
State/Province
Wales
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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