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

Primary Purpose

Brain Metastases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dose Escalated Five Fraction Stereotactic Radiosurgery
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Brain Metastases, Stereotactic Radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hazelrig-Salter Radiation Oncology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalated 5 Fraction Stereotactic Radiosurgery

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose of five fraction stereotactic radiotherapy
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

Secondary Outcome Measures

Acute toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire
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
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
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.

Full Information

First Posted
December 29, 2017
Last Updated
March 9, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03412812
Brief Title
A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases
Acronym
RAD1705
Official Title
A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Brain Metastases, Stereotactic Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalated 5 Fraction Stereotactic Radiosurgery
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Dose Escalated Five Fraction Stereotactic Radiosurgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose of five fraction stereotactic radiotherapy
Description
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
Time Frame
1-2 years
Secondary Outcome Measure Information:
Title
Acute toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire
Description
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.
Time Frame
1-2 years
Title
Late toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire
Description
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.
Time Frame
1-2 years
Title
Rate of local tumor control with five fraction stereotactic radiotherapy using Adverse Event questionnaire
Description
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.
Time Frame
1-2 years
Other Pre-specified Outcome Measures:
Title
Feasibility of capturing patient reported outcomes electronically using FACT-Br Questionnaire
Description
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
Time Frame
1-2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B Fiveash, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazelrig-Salter Radiation Oncology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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

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