Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.

Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.

Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.

Hypofractionated Radiosurgery

Bree Eaton, MD

This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.

PRIMARY OBJECTIVE:

To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week.

OUTLINE: This is a dose-escalation study.

Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks.

After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.

Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis

Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis

Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).

The median time to local brain progression will be calculated by Kaplan-Meier method with 95% CI.

The median time to distant brain progression will be calculated by Kaplan-Meier method with 95% CI.

The median of OS time with 95% CI will be calculated by Kaplan-Meier method.

Neurocognitive effect will be regressed over time using generalized estimating equation (GEE) model. The population change over time (slope) will be estimated with 95% CI.

QOL outcomes will be regressed over time using GEE model. The population change over time (slope) will be estimated with 95% CI.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Emory University

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife

Juergen Dunst, Prof.

Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.

Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).

Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Hypofractionated Radiosurgery for Localised Prostate Cancer

University of Luebeck

Saphir Radiosurgery Center Northern Germany

University Hospital Schleswig-Holstein

Prof. Dr. med. Juergen Dunst

Alexander Muacevic, Prof.

Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.

Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).

Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis	NCT01705548	Metastatic Mali... Unspecified Adu...	Hypofractionate...	18 Years -	Emory University
Hypofractionated Radiosurgery for Localised Prostate Cancer	NCT02635256	Prostate Cancer	Hypofractionate...	60 Years -	University Hospital Schleswig-Holstein
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)	NCT03795337	Prostate Cancer	Hypofractionate...	60 Years -	University Hospital Schleswig-Holstein

Spots Global Cancer Trial Database for hypofractionated radiosurgery