RecruitingPhase 2NCT05050929

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

Sponsor

British Columbia Cancer Agency

Enrollment

100 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Brain Metastases, Adult

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria11

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 Criteria12

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