QUARTZ - Quality of Life After Radiotherapy and Steroids

Phase 3

• Conditions: Brain and Central Nervous System Tumors; Lung Cancer; Cancer - Lung - Non small cell; Cancer - Brain

• Registration Number: ACTRN12607000264482
• Lead Sponsor: Tanya Holt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Histologically or cytologically proven primary Non Small Cell Lung Cancer- Computed Tomography(CT)/Magnetic Resonance Imaging (MRI) confirming brain metastases - Inoperable brain metastases as assessed by a lung cancer Multi-Disciplinary Team (MDT) or patients for whom surgery is deemed inappropriate- Clinician and patient uncertain of the role of WBRT- Patient able and willing to respond to questions in a weekly telephone assessment- Patient able and willing to give informed consent- Baseline Patient Assessment Form completed.

Exclusion Criteria

Clinician and / or patient certain that WBRT will be of benefit- Clinician and / or patient certain that WBRT will not be of benefit - Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons- Epidermal Growth Factor Receptor (EGFR) inhibitors within one week prior to randomisation- Chemotherapy (last cycle) within one month prior to randomisation- Previous radiotherapy to the brain- Surgery for brain metastases within one month prior to randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-assessed quality adjusted life years (QALY)[Quality of Life forms will be completed at baseline and every week, for the first 12 weeks, and then at least 4-weekly thereafter (until death), by the nurse phoning the patient (or face-to-face if the patient attends the hospital). The responses obtained each week for each patient will be converted (using the standard EQ5D scaling) to a utility score (between 0 and 1) which can be plotted over time. A QALY (equivalent to the Area Under the Curve) can then be calculated for each patient.]

Secondary Outcome Measures

Name	Time	Method
Karnofsky performance status: [Performance Status will be assessed weekly and the trial groups compared at specific timepoints (6 and 12 weeks). ];Patient symptoms: [Symptoms will be assessed by asking specific questions on a weekly basis for 12 weeks.];Assessment and measurement of caregiver concerns: [Carers concerns will be assessed by asking specific questions on a weekly basis for 12 weeks.];Overall survival: [Overall survival is the time between date of randomisation and date of death from any cause. Follow up will consist of weekly telephone assessments from randomisation, for a minimum of 12 weeks and then at least every 4 weeks until death. Also the patient should be reviewed in clinic by the investigating clinician at 4-weekly intervals unitl death. ]