RECRUITING

PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial

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Conditions

GliomaGlioma, MalignantRecurrent Glioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-30
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06397560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  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. 1. New areas of tumor outside the original radiotherapy fields as determined by the investigator.
  6. 2. Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment.
  7. 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.
  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.
  10. * Male condom plus spermicide
  11. * Cap plus spermicide
  12. * Diaphragm plus spermicide
  13. * Copper T
  14. * Progesterone T
  15. * Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
  16. * Implants
  17. * Hormone shot or injection
  18. * Combined pill
  19. * Mini-pill
  20. * Patch
  21. * Individuals assigned male at birth
  22. * Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
  23. * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50
  24. * Radiation-induced oophorectomy with last menses \> 1 year ago
  25. * Chemotherapy-induced menopause with \>1 year interval since last menses
  26. * Surgical sterilization (bilateral oophorectomy or hysterectomy)
  1. * Two or more courses of prior radiotherapy
  2. * Inability to undergo an MRI with contrast
  3. * Leptomeningeal evidence of recurrent disease
  4. * Multi-focal disease
  5. * Any other condition that may put a participant at higher risk, at the discretion of the investigator.

Contacts and Locations

Study Contact

Robert Press, M.D.
CONTACT
(786) 596-2000
Robert.Press@baptisthealth.net
Antoinette Pimental
CONTACT
(786) 596-2000
Antoinette.Pimentel@baptisthealth.net

Principal Investigator

Robert Press, M.D.
PRINCIPAL_INVESTIGATOR
Miami Cancer Institute at Baptist Health, Inc.

Study Locations (Sites)

Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, 33437
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

  • Robert Press, M.D., PRINCIPAL_INVESTIGATOR, Miami Cancer Institute at Baptist Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30
Study Completion Date2029-06

Study Record Updates

Study Start Date2025-04-30
Study Completion Date2029-06

Terms related to this study

Additional Relevant MeSH Terms

  • Glioma
  • Glioma, Malignant
  • Recurrent Glioma