Targeted radiation treatment for brain metastases
Randomized Phase II Non-Inferiority Study of 5-Day Versus 1-Day RAPid SimPLE (RAPPLE) Targeted Radiation Treatment for Brain Metastases
This study is testing if a single dose of targeted radiation can help people with brain metastases live as long as the standard treatment that takes longer to give.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Locations | 6 sites (Abbotsford British Columbia, British Columbia and 5 other locations) |
| Trial ID | NCT05050929 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of a single dose of 8 Gy targeted radiotherapy to brain metastases against the standard treatment of 20 Gy delivered over five sessions. It focuses on patients with poor prognosis and limited life expectancy, hypothesizing that the shorter treatment will provide equivalent overall survival. The study is designed as a randomized Phase II non-inferiority trial, with participants receiving either treatment and monitored for survival outcomes. The goal is to determine if the simplified approach can maintain quality of life while effectively managing brain metastases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a pathological diagnosis of a non-hematopoietic malignancy and brain metastases.
Not a fit: Patients with disseminated leptomeningeal carcinomatosis or those who have received whole brain radiotherapy within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more efficient and less burdensome option for patients with brain metastases, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown that shorter radiation schedules can be equally effective for other types of metastases, suggesting potential success for this approach in brain metastases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Abbotsford British Columbia, British Columbia and 5 other locations
- BC Cancer - Abbotsford — Abbotsford British Columbia, British Columbia, Canada (Recruiting)
- BC Cancer - Kelowna — Kelowna, British Columbia, Canada (Recruiting)
- BC Cancer - Prince George — Prince George, British Columbia, Canada (Recruiting)
- BC Cancer - Surrey — Surrey, British Columbia, Canada (Recruiting)
- BC Cancer - Vancouver — Vancouver, British Columbia, Canada (Recruiting)
- BC Cancer - Victoria — Victoria, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Alan Nichol, MD — BC Cancer Vancouver
- Study coordinator: Sandy Chang
- Email: sandy.chang@bccancer.bc.ca
- Phone: 604-877-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.