Clinical trial · Interventional
RAPid SimPLE 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
NCT05050929CI-TRIAL-00088661RAPPLEactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeting All Brain Metastases | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain Metastases
- description
- 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.
- interventionNames
- Radiation: Targeting All Brain Metastases
- type
- EXPERIMENTAL
- label
- 8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain Metastases
- description
- 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.
- interventionNames
- Radiation: Targeting All Brain Metastases
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Patients must fulfil all the following criteria to be eligible for admission to the 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 (DS-GPA) ≤ 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 calendar days of participant enrolment * Karnofsky Performance Score (KPS) ≥ 50 Exclusion Criteria Patients who fulfill any of the following criteria are not eligible for admission to the study: * 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 patient's safety, preclude safe administration of the planned protocol treatment, or prevent the patient 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
References
Publications (1)
- BACKGROUNDMulvenna 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 27604504