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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00403065 |
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 | Intervention | Phase |
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Brain and Central Nervous System Tumors Lung Cancer |
Drug: dexamethasone Procedure: quality-of-life assessment Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 1000 |
Study Start Date: | October 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have brain metastases confirmed by CT scan or MRI
The benefit or lack of benefit of whole-brain radiotherapy (WBRT) cannot be clearly defined
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Paula Mulvenna | Northern Centre for Cancer Treatment at Newcastle General Hospital |
Study ID Numbers: | CDR0000517194, MRC-LU24-QUARTZ, EU-20653, ISRCTN3826061, TROG 07.02 |
Study First Received: | November 21, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00403065 |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IV non-small cell lung cancer adult tumors metastatic to brain |
Dexamethasone Thoracic Neoplasms Non-small cell lung cancer Quality of Life Central Nervous System Neoplasms Recurrence Carcinoma Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Dexamethasone acetate Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Neoplasms by Site Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |