RAPid SimPLE Targeted Radiation Treatment for Brain Metastases

Launched by BRITISH COLUMBIA CANCER AGENCY · Sep 17, 2021

Keywords

ClinConnect Summary

The RAPid SimPLE clinical trial is studying a new way to treat brain metastases, which are cancer cells that have spread to the brain from other parts of the body. The goal is to see if a quicker and simpler type of targeted radiation treatment, giving 8 Gy in one session, is just as effective for overall survival as a more traditional approach that gives 20 Gy over five sessions. This trial is currently recruiting participants who are adults aged 18 and older and have a specific type of cancer that has spread to the brain. To qualify, patients should not be candidates for surgery, have a certain level of kidney function, and be willing to undergo regular follow-up imaging.

Participants in this study can expect to receive targeted radiotherapy and will be monitored closely throughout the process. They will also need to complete a questionnaire about their quality of life and agree to follow-up imaging appointments to track their progress. It's important to note that there are some criteria that would exclude a person from participating, such as having had certain recent surgeries or treatments, specific medical conditions, or being pregnant. This trial aims to provide valuable information about improving treatment options for patients with brain metastases.

Gender

ALL

Eligibility 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