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
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.
Study Design
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
Conditions
Lung Cancer
Intervention
dexamethasone, quality-of-life assessment, radiation therapy
Location
Wansbeck General Hospital
Ashington
England
United Kingdom
NE63 9JJ
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00403065
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Neoadjuvant Therapy
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Chemotherapy, Adjuvant
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Radon Daughters
Short-lived radioactive decay products of radon that include 216-Po, 214-Pb, 214-Bi, and 214-Po. They have an effective half-life of about 30 minutes and are solids that can deposit on the bronchial airways during inhalation and exhalation. This results in exposure of the respiratory airways to alpha radiation and can lead to diseases of the respiratory system, including lung cancer. (From Casarett and Doull's Toxicology, 4th ed, p740)
Quality Assurance, Health Care
Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
Quality-adjusted Life Years
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
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