RAPid SimPLE Targeted Radiation Treatment for Brain Metastases
NCT ID: NCT05050929
Last Updated: 2025-04-17
Study Results
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Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2022-07-01
2027-12-30
Brief Summary
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Detailed Description
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Justification The QUARTZ study randomized patients with brain metastases and poor prognosis between 20 Gy / 5 whole brain radiotherapy (WBRT) and best supportive care. The median survival in both arms of the study was 9 weeks. The quality of life in both arm was also the same. It is known that WBRT significantly diminishes quality of life. The investigators interpretation of the QUARTZ trial is that the unchecked growth of brain metastases in the best supportive care arm diminishes quality of life as much as WBRT. To control brain metastases without giving WBRT, targeted treatment with 20 Gy / 5 to the metastases alone is standard care at BC Cancer. Numerous randomized trials have compared the efficacy of 20-30 Gy / 5-10 fractions and 8 Gy / 1 for palliative treatment of pain from bone metastases. In addition, there is a randomized trial showing that 20 Gy / 5 and 8 Gy /1 are equally effective for the treatment of symptoms from spinal cord compression. This study will test the use of this shorter, one-visit treatment schedule against the standard 5-visit treatment schedule for patients with brain metastases.
Research Design Randomized Phase II Non-Inferiority Study. The estimated median survival for this cohort, based upon a prior cohort study from 2012-2016 at BC Cancer is 3 months (13 weeks). The investigators would regard a study median survival of less than the 9-week median survival observed in the QUARTZ trial as unacceptable. Hence, the hazard ratio for the experimental arm and the control arm is: 13 weeks / 9 weeks = 1.44. With one-sided Type I error set at alpha = 0.2 and power = 0.8, the investigators calculated a theoretical sample size of 86 patients. Based on prior experience with clinical trials for patients with brain metastases, a 15% risk of drop-out and loss to follow up is expected. Hence the final sample size will be 100 patients. Stratification by the diagnosis-specific graded prognostic assessment (DS-GPA) ranges of 0.0 - 1.0 and 1.5 - 2.0 and lung cancer versus other histologies will help to ensure baseline characteristics that predict for equal survival are equally distributed in both arms of the study.
Statistical Analysis The primary endpoint is overall survival. The study will be considered to be a positive phase II non-inferiority study if the median survival in the experimental arm is within 4 weeks of the median survival in the standard arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain Metastases
Five treatments of 4 Gy will be delivered using volumetric modulated arc therapy on a conventional linear accelerator in a conventional head shell without the use of stereotactic radiosurgery technique.
Targeting All Brain Metastases
Volumetric Modulated Arc Therapy
8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain Metastases
A single treatment of 8 Gy will be delivered using volumetric modulated arc therapy on a conventional linear accelerator in a conventional head shell without the use of stereotactic radiosurgery technique.
Targeting All Brain Metastases
Volumetric Modulated Arc Therapy
Interventions
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Targeting All Brain Metastases
Volumetric Modulated Arc Therapy
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18
* Pathological diagnosis of a non-hematopoietic malignancy
* Brain metastases of any size
* Any number of untreated or progressing, previously treated brain metastases that can all be contoured and targeted
* Presence of extracranial disease
* Diagnosis-Specific Graded Prognostic Assessment ≤ 2.0. (https://brainmetgpa.com/) or Graded Prognostic Assessment ≤ 2.0 (Appendix I)
* Able to complete the EuroQOL (EQ-5D-5L) questionnaire
* Willing and able to have regular imaging follow up
* Feasible to start protocol treatment within 14 days of participant enrolment
* Karnofsky Performance Score (KPS) ≥ 50
Exclusion Criteria
* Inability to have a brain MRI
* WBRT less than 3 months prior to randomization
* Disseminated leptomeningeal carcinomatosis (limited pachymeningeal disease is permitted)
* Multiple sclerosis
* Neurologically declining despite corticosteroids
* Appropriate for surgery or stereotactic radiosurgery
* Germ cell and primary brain tumours
* Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission
* Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines
* Pregnancy
* Potentially fertile men or women of childbearing potential who are unwilling to employ highly effective contraception
18 Years
100 Years
ALL
No
Sponsors
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Varian Medical Systems
INDUSTRY
British Columbia Cancer Agency
OTHER
Responsible Party
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Principal Investigators
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Alan Nichol, MD
Role: PRINCIPAL_INVESTIGATOR
BC Cancer Vancouver
Locations
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BC Cancer - Abbotsford
Abbotsford, British Columbia, Canada
BC Cancer - Kelowna
Kelowna, British Columbia, Canada
BC Cancer - Prince George
Prince George, British Columbia, Canada
BC Cancer - Surrey
Surrey, British Columbia, Canada
BC Cancer - Vancouver
Vancouver, British Columbia, Canada
BC Cancer - Victoria
Victoria, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Fred Hsu, BSc MD FRCPC
Role: primary
Sarah Baker, MD
Role: primary
References
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Mulvenna P, Nankivell M, Barton R, Faivre-Finn C, Wilson P, McColl E, Moore B, Brisbane I, Ardron D, Holt T, Morgan S, Lee C, Waite K, Bayman N, Pugh C, Sydes B, Stephens R, Parmar MK, Langley RE. Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial. Lancet. 2016 Oct 22;388(10055):2004-2014. doi: 10.1016/S0140-6736(16)30825-X. Epub 2016 Sep 4.
Other Identifiers
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H21-01343
Identifier Type: -
Identifier Source: org_study_id
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