Cohort B for Brain Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brain Cancer+2 More
Cohort B - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to test two de-escalated whole brain radiation therapy (WBRT) dose levels and assess their ability to maintain acceptable in-brain distant control.

Eligible Conditions
  • Brain Cancer
  • Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 1 year

1 year
Incidence of early and late adverse effects
6 months
Change in health-related quality of life
Change in neurocognitive function
Change in performance status
In-brain distant failure rate
Overall survival
Treated lesion control

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Cohort B
1 of 2
Cohort A
1 of 2

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Cohort B · No Placebo Group · N/A

Cohort B
Radiation
Experimental Group · 1 Intervention: Cohort B · Intervention Types: Radiation
Cohort A
Radiation
Experimental Group · 1 Intervention: Cohort A · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cohort B
2020
Completed Phase 1
~70
Cohort A
2020
Completed Phase 1
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Indiana UniversityLead Sponsor
870 Previous Clinical Trials
748,897 Total Patients Enrolled
Kevin R. Shiue, MDPrincipal InvestigatorIndiana University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The diagnosis of a solid tumor histology, regardless of its location in the body, is considered a pathology.
The volume of blood that a person can donate is limited to about 450 milliliters, which is the equivalent of a largest diameter of about 2.1 cm, assuming a perfect sphere.
You must be at least 18 years old to give consent.
The ability to provide written informed consent and HIPAA authorization.
The text is discussing the diagnosis of brain metastatic tumor lesions
The total volume of lesions is 30 cm3 or less.
No lesion larger than 5 cm³ is allowed.
The person is not a candidate for or eligible for Gamma Knife radiosurgery but refused it.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: November 10th, 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.