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NCT00403065

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

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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

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Lung Cancer Metastatic Cancer

Keywords

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recurrent non-small cell lung cancer stage IV non-small cell lung cancer tumors metastatic to brain

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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dexamethasone

Intervention Type DRUG

quality-of-life assessment

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Paula Mulvenna

Role: STUDY_CHAIR

Northern Centre for Cancer Treatment at Newcastle General Hospital

Locations

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Wansbeck General Hospital

Ashington, England, United Kingdom

Site Status

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, United Kingdom

Site Status

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

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Addenbrooke's Hospital

Cambridge, England, United Kingdom

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Papworth Hospital

Cambridge, England, United Kingdom

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Cumberland Infirmary

Carlisle, England, United Kingdom

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Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, United Kingdom

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Saint Richards Hospital

Chichester, England, United Kingdom

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Castle Hill Hospital

Cottingham, England, United Kingdom

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Walsgrave Hospital

Coventry, England, United Kingdom

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Darlington Memorial

Darlington, England, United Kingdom

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Derbyshire Royal Infirmary

Derby, England, United Kingdom

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Dorset County Hospital

Dorchester, England, United Kingdom

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University Hospital of North Durham

Durham, England, United Kingdom

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Bishop Auckland Hospital

Durham, England, United Kingdom

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Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

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Queen Elizabeth Hospital

Gateshead, England, United Kingdom

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Diana Princess of Wales Hospital

Grimsby, England, United Kingdom

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Hereford Hospitals

Hereford, England, United Kingdom

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Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

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Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, United Kingdom

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Ipswich Hospital

Ipswich, England, United Kingdom

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Queen Elizabeth Hospital

Kings Lynn, England, United Kingdom

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Cookridge Hospital

Leeds, England, United Kingdom

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