TerminatedPhase 3ACTRN12607000264482

QUARTZ - Quality of Life After Radiotherapy and Steroids

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 (in terms of Patient Assessed Quality Adjusted Life Years) 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

Sponsor

Tanya Holt

Enrollment

1,000 participants

Start Date

Mar 2, 2007

Study Type

Interventional

Conditions

Lung Cancer Brain and Central Nervous System Tumors

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study (QUARTZ) compares whole-brain radiotherapy plus steroids versus steroids alone in patients with brain metastases from non-small cell lung cancer that cannot be operated on. It is for adults aged 18 and older with confirmed lung cancer that has spread to the brain. Participants are randomly assigned to receive radiation plus steroids or steroids only, with quality of life as the main measure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Experimental Arm: Optimal Supportive Care (including dexamethasone) alone Optimal supportive care (OSC) includes a prescription of a proton pump inhibitor while on dexamethasone, parallel nursing sup

Experimental Arm: Optimal Supportive Care (including dexamethasone) alone Optimal supportive care (OSC) includes 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. Dexamethasone: the dexamethasone dose for patients in both arms of the study should be titrated down to the minimum required to control the patient’s symptoms of brain metastases. The timing and rate of dose reduction should be appropriate to the individual patient and be under the control of the treating clinician. Administration is orally. The duration also depends on individual patients requirments. OSC in both arms will continue as required by the patient until death.