Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases

Who is this study for? Patients with solid tumor brain metastases
What treatments are being studied? WBRT utilizing the PRDR technique+Memantine
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years at diagnosis of brain metastases.

• Eastern Cooperative Oncology Group (ECOG) Performance Score of \<2.

• Participants must have a biopsy-proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site) with intracranial lesions radiographically consistent with or pathologically proven to be brain metastases.

• Patients who have undergone prior systemic therapy are eligible.

• Life expectancy from extracranial disease greater than six months.

• Patients with measurable brain metastasis.

• Patients may have had prior therapy for brain metastasis, including stereotactic radiosurgery (SRS)and surgical resection. Patients must have completed prior therapy by at least 7 days prior to study enrollment for SRS and at least 14 days for surgical resection

• If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies.

• Creatinine clearance is ≥ 30 mL/min.

⁃ Start of PRDR WBRT within two weeks following registration.

⁃ Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English).

⁃ Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy.

⁃ Willing and able to give consent and to comply with treatment and follow-up schedule.

Locations
United States
Wisconsin
Clement J. Zablocki Veterans Affairs Medical Center
RECRUITING
Milwaukee
Froedtert Hospital & the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Medical College of Wisconsin Cancer Center Clinical Trials Office
cccto@mcw.edu
866-680-0505
Backup
Medical College of Wisconsin Cancer Center Clinical Trials Office, MS
cccto@mcw.edu
866-680-0505
Time Frame
Start Date: 2021-11-17
Estimated Completion Date: 2029-05
Participants
Target number of participants: 53
Treatments
Experimental: WBRT-PRDR plus memantine.
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov