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Trial Title:
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
NCT ID:
NCT06397560
Condition:
Glioma
Glioma, Malignant
Recurrent Glioma
Conditions: Official terms:
Glioma
Central Nervous System Neoplasms
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
PRDR
Description:
Proton pulsed reduced dose rate (PRDR) technique, to a dose of 54 Gy in 30 fractions
(treatments) with proton radiotherapy. Treatments will occur once per day on consecutive
weekdays.
Arm group label:
PRDR Radiotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lynn Cancer Institute at Baptist Health, Inc.
Address:
City:
Boca Raton
Zip:
33437
Country:
United States
Contact:
Last name:
Hina Saeed, M.D.
Phone:
561-374-5440
Email:
Hina.Saeed@baptisthealth.net
Facility:
Name:
Miami Cancer Institute at Baptist Health, Inc.
Address:
City:
Miami
Zip:
33176
Country:
United States
Contact:
Last name:
Robert Press, M.D.
Phone:
786-596-2000
Email:
Robert.Press@baptisthealth.net
Contact backup:
Last name:
Antoinette Pimental
Phone:
(786) 596-2000
Email:
Antoinette.Pimentel@baptisthealth.net
Investigator:
Last name:
Rupesh Kotecha, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Robert Press, M.D.
Email:
Principal Investigator
Start date:
November 2024
Completion date:
November 2028
Lead sponsor:
Agency:
Baptist Health South Florida
Agency class:
Other
Collaborator:
Agency:
Ion Beam Applications SA
Agency class:
Other
Source:
Baptist Health South Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06397560
https://baptisthealth.net/services/cancer-care
