RECRUITING

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique

Conditions

Brain Metastases whole-brain radiation therapy upfront pulsed reduced dose-rate

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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

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.

Official Title

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

Quick Facts

Study Start:2021-11-17

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05045950

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 Criteria	Exclusion Criteria
1. Age ≥18 years at diagnosis of brain metastases. 2. Eastern Cooperative Oncology Group (ECOG) Performance Score of \<2. 3. 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. 4. Patients who have undergone prior systemic therapy are eligible. 5. Life expectancy from extracranial disease greater than six months. 6. Patients with measurable brain metastasis. 7. 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 8. If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies. 9. Creatinine clearance is ≥ 30 mL/min. 10. Start of PRDR WBRT within two weeks following registration. 11. Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English). 12. Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy. 13. Willing and able to give consent and to comply with treatment and follow-up schedule.	1. Metastases from hematological malignancy, or central nervous system malignancy. 2. Patients whose malignancy is being treated with curative intent. 3. Leptomeningeal metastases. 4. Contraindication to MRI imaging with contrast. 5. Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists. 6. Stage IV-V chronic kidney disease or end-stage renal disease. 7. Participants with a maximum tumor diameter exceeding 5 cm (if not resected). 8. Prior cranial whole brain radiation therapy. 9. Past medical history of dementia which is thought to be unrelated to the brain metastases. 10. 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. 11. 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. 12. Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years at diagnosis of brain metastases.
2. Eastern Cooperative Oncology Group (ECOG) Performance Score of \<2.
3. 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.
4. Patients who have undergone prior systemic therapy are eligible.
5. Life expectancy from extracranial disease greater than six months.
6. Patients with measurable brain metastasis.
7. 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
8. If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies.
9. Creatinine clearance is ≥ 30 mL/min.
10. Start of PRDR WBRT within two weeks following registration.
11. Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English).
12. Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy.
13. Willing and able to give consent and to comply with treatment and follow-up schedule.

1. Metastases from hematological malignancy, or central nervous system malignancy.
2. Patients whose malignancy is being treated with curative intent.
3. Leptomeningeal metastases.
4. Contraindication to MRI imaging with contrast.
5. Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists.
6. Stage IV-V chronic kidney disease or end-stage renal disease.
7. Participants with a maximum tumor diameter exceeding 5 cm (if not resected).
8. Prior cranial whole brain radiation therapy.
9. Past medical history of dementia which is thought to be unrelated to the brain metastases.
10. 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.
11. 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.
12. Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505

cccto@mcw.edu

Medical College of Wisconsin Cancer Center Clinical Trials Office, MS

CONTACT

866-680-0505

cccto@mcw.edu

Principal Investigator

Lindsay Puckett, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Clement J. Zablocki Veterans Affairs Medical Center

Milwaukee, Wisconsin, 53295

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Lindsay Puckett, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

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 Date2021-11-17

Study Completion Date2026-05

Study Record Updates

Study Start Date2021-11-17

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

whole-brain radiation therapy
upfront pulsed reduced dose-rate

Additional Relevant MeSH Terms

Brain Metastases