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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|ClinicalTrials.gov Identifier: NCT00403065|
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic Cancer||Drug: dexamethasone Procedure: quality-of-life assessment Radiation: radiation therapy||Phase 3|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|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 Start Date :||October 2006|
|Actual Study Completion Date :||March 2013|
- Patient-assessed quality adjusted life years
- Overall survival
- Karnofsky performance status
- Patient symptoms
- Assessment and measurement of caregiver concerns
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403065
|Study Chair:||Paula Mulvenna||Northern Centre for Cancer Treatment at Newcastle General Hospital|