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 Overview
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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.

Official Title
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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

Conditions
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Lung Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: dexamethasone
* Procedure: quality-of-life assessment
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone|nan|
|Procedure: quality-of-life assessment|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-assessed quality adjusted life years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Karnofsky performance status |  |  | 
| Patient symptoms |  |  | 
| Assessment and measurement of caregiver concerns |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, tumors metastatic to brain