NCT06397560 PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
| NCT ID | NCT06397560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baptist Health South Florida |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2025-04-30 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to see if a specific type of radiation therapy, called "proton pulsed reduced dose rate" or "PRDR radiotherapy" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a "recurrent high-grade glioma" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.
Eligibility Criteria
Inclusion Criteria: * Karnofsky performance status ≥ 50 * Histologically-confirmed or radiographic evidence of recurrent / progressive glioma * Prior treatment with radiotherapy to a minimum dose of 45 Gy * 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: 1. New areas of tumor outside the original radiotherapy fields as determined by the investigator. 2. Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment. 3. 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. * 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 * 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: * Male condom plus spermicide * Cap plus spermicide * Diaphragm plus spermicide * Copper T * Progesterone T * Levonorgestrel-releasing intrauterine system (e.g., Mirena®) * Implants * Hormone shot or injection * Combined pill * Mini-pill * Patch Individuals who meet any of the following criteria will not need contraception: * Individuals assigned male at birth * Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50 * Radiation-induced oophorectomy with last menses \> 1 year ago * Chemotherapy-induced menopause with \>1 year interval since last menses * Surgical sterilization (bilateral oophorectomy or hysterectomy) Exclusion Criteria: * Two or more courses of prior radiotherapy * Inability to undergo an MRI with contrast * Leptomeningeal evidence of recurrent disease * Multi-focal disease * Any other condition that may put a participant at higher risk, at the discretion of the investigator.
Contact & Investigator
Robert Press, M.D.
PRINCIPAL INVESTIGATOR
Miami Cancer Institute at Baptist Health, Inc.
Frequently Asked Questions
Who can join the NCT06397560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06397560 currently recruiting?
Yes, NCT06397560 is actively recruiting participants. Contact the research team at Robert.Press@baptisthealth.net for enrollment information.
Where is the NCT06397560 trial being conducted?
This trial is being conducted at Boca Raton, United States, Miami, United States.
Who is sponsoring the NCT06397560 clinical trial?
NCT06397560 is sponsored by Baptist Health South Florida. The principal investigator is Robert Press, M.D. at Miami Cancer Institute at Baptist Health, Inc.. The trial plans to enroll 28 participants.