Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000264482
Ethics application status
Approved
Date submitted
16/05/2007
Date registered
17/05/2007
Date last updated
3/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
QUARTZ - Quality of Life After Radiotherapy and Steroids
Scientific 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 (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
Secondary ID [1] 366 0
ClinicalTrials.gov: NCT00403065
Universal Trial Number (UTN)
Trial acronym
TROG 07.02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors
 1803 0
Lung Cancer 1804 0
Condition category
Condition code
Cancer 1891 1891 0 0
Lung - Non small cell
Cancer 1892 1892 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1757 0
Treatment: Other
Intervention code [2] 1949 0
Treatment: Drugs
Comparator / control treatment
Control Arm: Optimal Supportive Care (OSC, including dexamethasone) with whole brain radiotherapy (WBRT, 20 Gy in 5 consecutive daily fractions)
Control group
Active

Outcomes
Primary outcome [1] 2691 0
Patient-assessed quality adjusted life years (QALY)
Timepoint [1] 2691 0
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 [1] 4546 0
Overall survival:
Timepoint [1] 4546 0
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.
Secondary outcome [2] 4547 0
Karnofsky performance status:
Timepoint [2] 4547 0
Performance Status will be assessed weekly and the trial groups compared at specific timepoints (6 and 12 weeks).
Secondary outcome [3] 4548 0
Patient symptoms:
Timepoint [3] 4548 0
Symptoms will be assessed by asking specific questions on a weekly basis for 12 weeks.
Secondary outcome [4] 4549 0
Assessment and measurement of caregiver concerns:
Timepoint [4] 4549 0
Carers concerns will be assessed by asking specific questions on a weekly basis for 12 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/06/2007
Actual
2/03/2007
Date of last participant enrolment
Anticipated
Actual
8/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2038 0
Other Collaborative groups
Name [1] 2038 0
Trans Tasman Radiation Oncology Group Seed Funding
Country [1] 2038 0
Australia
Funding source category [2] 2489 0
Government body
Name [2] 2489 0
NHMRC Palliative Care Research Program Grant
Country [2] 2489 0
Australia
Primary sponsor type
Individual
Name
Tanya Holt
Address
Queensland Radium Institute Mater Centre Raymond Terrace South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 1846 0
Other Collaborative groups
Name [1] 1846 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 1846 0
Edith St
Waratah
NSW 2298
Country [1] 1846 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3772 0
Princess Alexandra Hospital
Ethics committee address [1] 3772 0
Ethics committee country [1] 3772 0
Australia
Date submitted for ethics approval [1] 3772 0
Approval date [1] 3772 0
01/02/2007
Ethics approval number [1] 3772 0
Ethics committee name [2] 3773 0
Peter MacCallum Cancer Centre
Ethics committee address [2] 3773 0
Ethics committee country [2] 3773 0
Australia
Date submitted for ethics approval [2] 3773 0
Approval date [2] 3773 0
Ethics approval number [2] 3773 0
Ethics committee name [3] 3774 0
Mater Centre
Ethics committee address [3] 3774 0
Brisbane
Ethics committee country [3] 3774 0
Australia
Date submitted for ethics approval [3] 3774 0
Approval date [3] 3774 0
Ethics approval number [3] 3774 0

Summary
Brief 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.
Trial website
www.trog.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27860 0
Dr Tanya Holt
Address 27860 0
Queensland Radium Institute Mater Centre Raymond Terrace South Brisbane QLD 4101
Country 27860 0
Australia
Phone 27860 0
+61 7 38403222
Fax 27860 0
Email 27860 0
[email protected]
Contact person for public queries
Name 10946 0
Ms Kacy Baumann
Address 10946 0
Queensland Radium Institute
Mater Centre
Raymond Terrace
South Brisbane QLD 4101
Country 10946 0
Australia
Phone 10946 0
+61 7 38403219
Fax 10946 0
+61 7 38403298
Email 10946 0
[email protected]
Contact person for scientific queries
Name 1874 0
Dr Tanya Holt
Address 1874 0
Queensland Radium Institute
Mater Centre
Raymond Terrace
South Brisbane QLD 4101
Country 1874 0
Australia
Phone 1874 0
+61 7 38403222
Fax 1874 0
+61 7 38403399
Email 1874 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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