PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial (NCT06397560)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Karnofsky performance status ≥ 50
2. Histologically-confirmed or radiographic evidence of recurrent / progressive glioma
3. Prior treatment with radiotherapy to a minimum dose of 45 Gy
4. At least 6 months or greater between completion of prior radiotherapy and enrollment in this study. If prospective participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:
5. New areas of tumor outside the original radiotherapy fields as determined by the investigator.
6. Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment.
7. Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of enrollment AND an interval of at least 90 days between completion of radiotherapy and enrollment.
8. Must have recovered from grade 3+ toxicities of prior therapy and there must be a minimum time of 28 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy
9. Must not be pregnant (positive pregnancy test) or breastfeeding. Must agree to use of highly effective contraception during radiotherapy treatment and for an additional 6 months. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. Highly effective and acceptable forms of contraception are:
10. Male condom plus spermicide
11. Cap plus spermicide
12. Diaphragm plus spermicide

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

• Lynn Cancer Institute at Baptist Health, Inc. — Boca Raton, Florida
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.