RAPid SimPLE Targeted Radiation Treatment for Brain Metastases
RAPPLE
Randomized Phase II Non-Inferiority Study of 5-Day Versus 1-Day RAPid SimPLE (RAPPLE) Targeted Radiation Treatment for Brain Metastases
1 other identifier
interventional
100
1 country
6
Brief Summary
The aim of the study is to show that rapid, simple targeted radiotherapy to brain metastases with 8 Gy / 1 is non-inferior to 20 Gy / 5 in terms of overall survival for patients with poor prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2022
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
September 21, 2021
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
April 17, 2025
April 1, 2025
4.5 years
August 4, 2021
April 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival Time
The median time from randomization to death
1 year
Secondary Outcomes (7)
Median Time to Decline in Karnofsky Performance Status
1 year
Control of treated brain metastases
1 year
Corticosteroid use
6 weeks
Control of brain disease
1 year
Retreatments for brain metastases
1 year
- +2 more secondary outcomes
Study Arms (2)
20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain Metastases
ACTIVE COMPARATORFive 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.
8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain Metastases
EXPERIMENTALA 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.
Interventions
Volumetric Modulated Arc Therapy
Eligibility Criteria
You may qualify if:
- Subjects must meet all of the following criteria to be eligible for participation in this study:
- 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
You may not qualify if:
- Subjects are excluded from the study if any of the following criteria apply:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- British Columbia Cancer Agencylead
- Varian Medical Systemscollaborator
Study Sites (6)
BC Cancer - Abbotsford
Abbotsford, British Columbia, Canada
BC Cancer - Kelowna
Kelowna, British Columbia, V1Y5L3, Canada
BC Cancer - Prince George
Prince George, British Columbia, V2M7E9, Canada
BC Cancer - Surrey
Surrey, British Columbia, Canada
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
BC Cancer - Victoria
Victoria, British Columbia, Canada
Related Publications (1)
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.
PMID: 27604504BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Nichol, MD
BC Cancer Vancouver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2021
First Posted
September 21, 2021
Study Start
July 1, 2022
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2027
Last Updated
April 17, 2025
Record last verified: 2025-04