PRDR WBRT for Brain Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byHina Saeed, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Medical College of Wisconsin
Must not be taking: NMDA antagonists
Disqualifiers: Hematological malignancy, Leptomeningeal metastases, Dementia, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking memantine or other NMDA antagonists, you may need to stop, as these are contraindicated.
What data supports the effectiveness of the treatment WBRT for brain cancer?
Whole Brain Radiation Therapy (WBRT) is commonly used to manage brain metastases (cancer spread to the brain) and can help control symptoms. It is often used after surgery to improve local control of the disease, especially in patients whose cancer outside the brain is under control.
12345Is whole-brain radiation therapy (WBRT) safe for humans?
Whole-brain radiation therapy (WBRT) is generally considered safe, but it can have side effects. Early side effects are usually mild, but late complications can affect brain function and quality of life. Research is ongoing to reduce these risks, such as using techniques to protect certain brain areas.
34678How is the treatment WBRT for brain cancer different from other treatments?
Whole Brain Radiation Therapy (WBRT) is unique because it targets the entire brain to control symptoms in patients with brain metastases, unlike other treatments that may focus on specific areas to avoid side effects. It is often used when there are multiple metastases or after surgery to reduce the chance of cancer returning, but it may not improve overall survival.
123910Eligibility Criteria
This trial is for adults over 18 with brain metastases from solid tumors, expected to live more than six months. They must have a good performance status, be able to do neurocognitive tests, and start treatment within two weeks of joining. Prior treatments are okay except whole brain radiation. Pregnant women or those not using contraception, non-English speakers, and patients with certain medical conditions are excluded.Inclusion Criteria
Creatinine clearance is ≥ 30 mL/min
I have had treatment that affects my whole body.
I was 18 or older when my brain cancer was diagnosed.
+10 more
Exclusion Criteria
Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician, prevent informed consent or completion of protocol treatment, and/or follow-up visits
I have had whole brain radiation therapy before.
Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 weeks
Treatment
Participants receive Whole-brain radiation therapy (WBRT) using the pulsed reduced dose rate (PRDR) technique, with a dose of 30 Gy in 10 fractions. Memantine is administered starting one to two days prior to WBRT and continues for up to 24 weeks.
2 weeks for WBRT, up to 24 weeks for Memantine
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on neurocognitive outcomes and clinical patient outcomes associated with radiation treatment of brain metastases.
4 weeks
Participant Groups
The study tests Whole-brain radiation therapy (WBRT) using a Pulsed Reduced Dose-Rate (PRDR) technique alongside Memantine medication. Patients will receive daily WBRT sessions in ten fractions totaling 30 Gy via the PRDR method to optimize neurocognition in brain tumor treatment.
1Treatment groups
Experimental Treatment
Group I: WBRT-PRDR plus memantine.Experimental Treatment2 Interventions
Study patients will receive WBRT-PRDR within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique. Memantine should ideally start two days (or one day) prior to WBRT PRDR and must start no later than the fourth WBRT PRDR treatment and will continue for a maximum of 24 weeks (≈six months). Memantine will be administered as per standard institutional guidelines.
WBRT is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
🇺🇸 Approved in United States as Whole Brain Radiation Therapy for:
- Brain metastases
- Cancer treatment
🇪🇺 Approved in European Union as Whole-Brain Radiotherapy for:
- Brain metastases
- Cancer treatment
🇨🇦 Approved in Canada as WBRT for:
- Brain metastases
- Cancer treatment
🇯🇵 Approved in Japan as Whole Brain Radiation Therapy for:
- Brain metastases
- Cancer treatment
🇨🇳 Approved in China as Whole-Brain Radiotherapy for:
- Brain metastases
- Cancer treatment
🇨🇭 Approved in Switzerland as WBRT for:
- Brain metastases
- Cancer treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Froedtert Hospital & the Medical College of WisconsinMilwaukee, WI
Clement J. Zablocki Veterans Affairs Medical CenterMilwaukee, WI
Loading ...
Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Poor outcomes after whole brain radiotherapy in patients with brain metastases: results from an international multicentre cohort study. [2013]To describe the characteristics and outcomes of cancer patients receiving Whole Brain Radiotherapy (WBRT) and delineate poor outcome groups after WBRT.
Treatment of solitary brain metastasis. Resection followed by whole brain radiation therapy (WBRT) and a radiation boost to the metastatic site. [2022]Whole brain radiation therapy (WBRT) is reported to improve local control after resection of brain metastases. Improvement of survival was only observed in patients with controlled extracranial disease. The optimum radiation schedule has yet to be defined. The authors' experience with a postoperative approach including WBRT and a radiation boost to the metastatic site is presented.
Prognostic factors in brain metastases: can we determine patients who do not benefit from whole-brain radiotherapy? [2019]Whole-brain radiotherapy (WBRT) is a standard treatment recommendation for patients with brain metastases. The goal of treatment is symptom control, which in the short run can be often achieved by steroids. Patients with a short life expectancy may not derive benefit from the addition of radiation. The ability to identify this group would aid the decision of whether to recommend WBRT.
Whole brain radiotherapy with radiosensitizer for brain metastases. [2021]To study the efficacy of whole brain radiotherapy (WBRT) with radiosensitizer in comparison with WBRT alone for patients with brain metastases in terms of overall survival, disease progression, response to treatment and adverse effects of treatment.
Brain metastases treated with radiosurgery alone: an alternative to whole brain radiotherapy? [2022]Whole brain radiotherapy (WBRT) provides benefit for patients with brain metastases but may result in neurological toxicity for patients with extended survival times. Stereotactic radiosurgery in combination with WBRT has become an important approach, but the value of WBRT has been questioned. As an alternative to WBRT, we managed patients with stereotactic radiosurgery alone, evaluated patients' outcomes, and assessed prognostic factors for survival and tumor control.
Assessment of Risk of Xerostomia After Whole-Brain Radiation Therapy and Association With Parotid Dose. [2022]Whole-brain radiation therapy (WBRT) delivers a substantial radiation dose to the parotid glands, but the parotid glands are not delineated for avoidance and xerostomia has never been reported as an adverse effect. Minimizing the toxic effects in patients receiving palliative treatments, such as WBRT, is crucial.
Treatment of brain metastases in lung cancer: strategies to avoid/reduce late complications of whole brain radiation therapy. [2021]Brain metastases occur in 20-40 % of lung cancer patients. The use of whole brain radiation therapy (WBRT) has been shown to ameliorate many neurological symptoms, facilitate corticosteroid reduction, enhance quality of life (QOL), and prolong survival. The acute and early delayed side effects of WBRT are generally mild and inconsequential, whereas late complications often are progressive, irreversible, and may have a profound effect on neurocognitive function and QOL. Nevertheless, WBRT remains the cornerstone for treatment of multiple brain metastases due to its efficacy and the paucity of other treatment options. In avoidance of WBRT and its potential toxicity, patients of good performance status and ≤3 metastases may be treated reasonably with focal therapy alone (surgery or radiosurgery) without a compromise in survival. In patients with multiple brain metastases and those undergoing prophylactic cranial irradiation (PCI), established methods to mitigate the late complications of WBRT include total dose observation, dose per fraction restrictions, and avoidance of concomitant chemotherapy. Current areas of active research that hold great potential for benefit include hippocampal-sparing radiotherapy and the use of neuroprotective agents.
Leukoencephalopathy after whole-brain radiation therapy plus radiosurgery versus radiosurgery alone for metastatic lung cancer. [2022]As systemic therapies improve and patients live longer, concerns mount about the toxicity of whole-brain radiation therapy (WBRT) for treatment of brain metastases. Development of delayed white matter abnormalities indicative of leukoencephalopathy have been correlated with cognitive dysfunction. This study assesses the risk of imaging-defined leukoencephalopathy in patients whose management included WBRT in addition to stereotactic radiosurgery (SRS). This risk is compared to patients who only underwent SRS.
Involved field radiation therapy after surgical resection of solitary brain metastases--mature results. [2021]Whole brain radiation therapy (WBRT) reduces local recurrence in patients after surgical resection of brain metastases without improving overall survival. Involved field radiation therapy (IFRT) has been used at our center to avoid delayed neurotoxicity associated with WBRT in well-selected patients with surgically resected single brain metastases. The purpose of this study was to evaluate the long-term outcomes of these patients.
The treatment of patients with 1-3 brain metastases: is there a place for whole brain radiotherapy alone, yet? A retrospective analysis. [2022]To evaluate the efficacy of whole brain radiotherapy (WBRT) with or without other treatments in patients (pts) with 1-3 brain metastases (BM).