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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403065
• Other study ID #: CDR0000517194
• Secondary ID: MRC-LU24-QUARTZE
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2006
• Last updated: August 23, 2013
• Start date: October 2006
• Est. completion date: March 2013

Study information

• Verified date: January 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• dexamethasone

Procedure:
• quality-of-life assessment

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Wansbeck General Hospital	Ashington	England
United Kingdom	Centre for Cancer Research and Cell Biology at Queen's University Belfast	Belfast	Northern Ireland
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Papworth Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Cumberland Infirmary	Carlisle	England
United Kingdom	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England
United Kingdom	Saint Richards Hospital	Chichester	England
United Kingdom	Castle Hill Hospital	Cottingham	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Darlington Memorial	Darlington	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Bishop Auckland Hospital	Durham	England
United Kingdom	University Hospital of North Durham	Durham	England
United Kingdom	Hairmyres Hospital	East Kilbride	Scotland
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Queen Elizabeth Hospital	Gateshead	England
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	Hereford Hospitals	Hereford	England
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	Princess Royal Hospital at Hull and East Yorkshire NHS Trust	Hull	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Crosshouse Hospital	Kilmarnock	Scotland
United Kingdom	Queen Elizabeth Hospital	King's Lynn	England
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Llandough Hospital	Llandough	Wales
United Kingdom	Guy's Hospital	London	England
United Kingdom	Homerton University Hospital	London	England
United Kingdom	Newham University Hospital	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. Mary's Hospital	London	England
United Kingdom	UCL Cancer Institute	London	England
United Kingdom	Whipps Cross Hospital	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	North Tyneside Hospital	North Shields	England
United Kingdom	Friarage Hospital	North Yorkshire	England
United Kingdom	Northampton General Hospital	Northampton	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	George Eliot Hospital	Nuneaton	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Whiston Hospital	Prescot Merseyside	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Alexandra Healthcare NHS	Redditch, Worcestershire	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	South Tyneside District Hospital	South Shields	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Southport and Formby District General Hospital	Southport	England
United Kingdom	University Hospital of North Tees	Stockton-On-Tees	England
United Kingdom	Taunton and Somerset Hospital	Taunton	England
United Kingdom	Torbay Hospital	Torquay	England
United Kingdom	Royal Cornwall Hospital	Truro	England
United Kingdom	Walsall Manor Hospital	Walsall	England
United Kingdom	South Warwickshire Hospital	Warwick, Warwickshire	England
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Worcester Royal Hospital	Worcester	England
United Kingdom	Cancer Care Centre at York Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-assessed quality adjusted life years			No
Secondary	Overall survival			No
Secondary	Karnofsky performance status			No
Secondary	Patient symptoms			No
Secondary	Assessment and measurement of caregiver concerns			No