Hypofractionated Radiosurgery for Unspecified Adult Solid Tumor, Protocol Specific

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Unspecified Adult Solid Tumor, Protocol Specific+4 More
Hypofractionated Radiosurgery - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at the side effects and best dose of a type of radiation therapy called stereotactic radiosurgery in treating patients with large brain metastasis.

Eligible Conditions
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Metastatic Malignant Neoplasm to Brain

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 2 years

4 months
Distant control: lack of progression of disease in surrounding brain as defined by RECIST criteria
Local control; lack of progression of disease in resection cavity as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Maximum tolerated dose (MTD) of hypofractionated radiosurgery defined as the highest dose level where a grade 3 or greater with an attribution score of ≥ 3 develops in ≤ 2 of 6 patients in a dose group
Up to 2 years
Freedom from failure/progression free survival
Long-term neurocognitive outcomes: using the Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam (MMSE) and Cognitive Functioning Subscale of the Medical Outcomes Scale (MOS)
Neurologic toxicity due to treatment, graded according to the CTCAE version 4.03
Overall survival (OS): death from any cause
Quality of life (QOL) outcomes: using the quality of life questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).

Trial Safety

Trial Design

1 Treatment Group

Hypofractionated Radiosurgery
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Hypofractionated Radiosurgery · No Placebo Group · N/A

Hypofractionated Radiosurgery
Radiation
Experimental Group · 1 Intervention: Hypofractionated Radiosurgery · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiosurgery
2015
N/A
~90

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,503 Previous Clinical Trials
2,706,562 Total Patients Enrolled
Bree Eaton, MDPrincipal InvestigatorEmory University

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have one brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.