A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases (RAD1705)

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ClinicalTrials.gov Identifier: NCT03412812

Recruitment Status : Recruiting

First Posted : January 26, 2018

Last Update Posted : March 28, 2022

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Sponsor:

Information provided by (Responsible Party):

John Fiveash, MD, University of Alabama at Birmingham

Tracking Information

First Submitted Date ^ICMJE

December 29, 2017

First Posted Date ^ICMJE

January 26, 2018

Last Update Posted Date

March 28, 2022

Actual Study Start Date ^ICMJE

July 30, 2018

Estimated Primary Completion Date

January 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum tolerated dose of five fraction stereotactic radiotherapy [ Time Frame: 1-2 years ]

To determine the maximum tolerated dose of five fraction stereotactic radiotherapy for patients with either tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Acute toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire [ Time Frame: 1-2 years ]
To assess the acute toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Late toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire [ Time Frame: 1-2 years ]
To assess the late toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Rate of local tumor control with five fraction stereotactic radiotherapy using Adverse Event questionnaire [ Time Frame: 1-2 years ]
To determine the rate of local tumor control with five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Feasibility of capturing patient reported outcomes electronically using FACT-Br Questionnaire [ Time Frame: 1-2 years ]

To assess the feasibility of capturing patient reported outcomes with the Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br) electronically in the Radiation Oncology clinic

Original Other Pre-specified Outcome Measures

Same as current

Descriptive Information

Brief Title ^ICMJE

A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases

Official Title ^ICMJE

A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain

Brief Summary

This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.

Detailed Description

This study looks at dose escalation treatment in patients diagnosed with brain metastases. Treatment involve five fraction stereotactic radiotherapy for patients with brain tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter and dose escalation treatment is delivered only to the single largest tumor while all other tumors are treated with standard of care practices if they are present. A dose escalation schedule is proposed based on the monitoring of CNS toxicity and tumor size of the largest tumor, given it falls into the parameters set on diameter.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Brain Metastases

Intervention ^ICMJE

Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery

As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.

Study Arms ^ICMJE

Experimental: Dose Escalated 5 Fraction Stereotactic Radiosurgery

Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Tumors must fall into one of two categories: 2.1-4.0cm diameter or 4.1-6.0 cm diameter. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.

Intervention: Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

February 2023

Estimated Primary Completion Date

January 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All patients must have histologically confirmed malignancy.
All patients must have imaging suggestive of one or more brain metastases.
Karnofsky performance status (KPS) ≥ 60
Age > 18 years
Patients must provide written informed consent to participate in the study.
Patients must have less than or equal to 10 brain metastases as identified on brain MRI.

Exclusion Criteria:

History of surgical resection to the tumor of interest
History of radiation to the tumor of interest
History of previous whole brain irradiation
Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents.
Patient is unable to have MRI or MRI contrast.
Inability to meet the appropriate normal tissue dose constraints secondary to tumor location should result in exclusion of the patient / tumor.
Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Kristin P Webb, CCRP	205-934-5670	kkwebb@uabmc.edu
Contact: John B Fiveash, MD		jfiveash@uabmc.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03412812

Other Study ID Numbers ^ICMJE

IRB-300001065

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

John Fiveash, MD, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John B Fiveash, MD

University of Alabama at Birmingham

PRS Account

University of Alabama at Birmingham

Verification Date

March 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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