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Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases

Primary Purpose

Metastatic Malignant Neoplasm in the Brain

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Frameless Fractionated Stereotactic Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

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

Inclusion Criteria:

  • All patients with 1-4 metastatic brain lesions who are considered eligible for single-fraction, frame-based SRS, who are unable or unwilling to undergo frame-based SRS
  • One to 4 untreated metastatic brain lesions
  • Each brain lesion must be less than or equal to 5 cm in diameter and not an optimal surgical candidate
  • Patient must be able have a magnetic resonance imaging (MRI) of the brain for treatment planning
  • Histologic confirmation of malignancy
  • For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment
  • Glomerular filtration rate (GFR) adequate for intravenous (IV) contrast delivery for imaging
  • No concurrent chemotherapy
  • Patient may have had prior therapy for brain metastasis, including radiosurgery and surgical resection at the discretion of the treating physician however only new untreated lesions will be followed on protocol.

Exclusion Criteria:

  • Five or more metastatic brain lesions
  • Brain lesion(s) greater than 5 cm in diameter
  • Lesion(s) involving the brainstem, optic chiasm or optic nerve(s)
  • Patients unable to have IV contrast for computed tomography (CT) and MRI imaging
  • Patient unable to have an MRI of the brain
  • Patients willing to be treated with frame-based gamma knife SRS at MD Anderson main campus or MD Anderson at the Woodlands
  • Positive pregnant status confirmed by serum or urine pregnancy test
  • Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not optimally treated with SRS
  • Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT
  • Prior whole brain radiotherapy or conventional external beam radiotherapy

Sites / Locations

  • Presbyterian Hospital
  • MD Anderson in The Woodlands
  • M D Anderson Cancer Center
  • MD Anderson West Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (FFSRT)

Arm Description

Patients undergo FFSRT daily over 30 minutes for 3-5 days.

Outcomes

Primary Outcome Measures

Incidence of lesion failure based on imagining assessments for each lesion
Rates of local control
Intracranial progression free survival (PFS)
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial PFS.
Overall survival (OS)
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial OS.
Cost data
Will be summarized using descriptive statistics such as mean, median, standard deviation, and range. Comparisons in cost between treatment modalities will be evaluated using a paired t-test where each patient will serve as his or her own control to determine if the cost of frameless fractionated stereotactic radiation therapy (FFSRT) is comparable to standard treatment.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2016
Last Updated
April 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02798029
Brief Title
Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases
Official Title
A Phase II Study of the Efficacy, Safety, and Cost of Frameless Fractionated Stereotactic Radiation for Parenchymal Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 8, 2016 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
This phase II trial studies the safety and efficacy of frameless fractionated stereotactic radiation therapy for brain metastases. Frameless fractionated stereotactic radiosurgery is a specialized radiation therapy that delivers 3 to 5, high dose fractions of radiation directly to the brain lesions while sparing normal tissues.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the efficacy and safety of frameless fractionated stereotactic radiation therapy (FFSRT) on the treatment of solitary and oligometastatic brain metastases in the MD Anderson Houston Area Locations, MD Anderson Radiation Treatment Centers in New Mexico, MD Anderson affiliates and the main campus of MD Anderson, for patients unable or unwilling to undergo frame-based stereotactic radiosurgery (SRS). SECONDARY OBJECTIVES: I. To assess 6-month local control, intracranial progression-free survival and overall survival. II. To collect data on charges and reimbursements of patients treated with FFSRT to compare those charges and reimbursements if the same patients had been treated with single-fraction, frame-based gamma knife SRS. OUTLINE: Patients undergo FFSRT daily over 30 minutes for 3-5 days. After completion of study treatment, patients are followed up every 3 months for up to 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Malignant Neoplasm in the Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (FFSRT)
Arm Type
Experimental
Arm Description
Patients undergo FFSRT daily over 30 minutes for 3-5 days.
Intervention Type
Radiation
Intervention Name(s)
Frameless Fractionated Stereotactic Radiation Therapy
Other Intervention Name(s)
FFSRT, Frameless SRT, FSRS
Primary Outcome Measure Information:
Title
Incidence of lesion failure based on imagining assessments for each lesion
Time Frame
Up to 1 year
Title
Rates of local control
Time Frame
Up to 1 year
Title
Intracranial progression free survival (PFS)
Description
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial PFS.
Time Frame
From enrollment to either the first observation of progression disease in the brain or death due to any cause, assessed up to 1 year
Title
Overall survival (OS)
Description
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial OS.
Time Frame
Up to 1 year
Title
Cost data
Description
Will be summarized using descriptive statistics such as mean, median, standard deviation, and range. Comparisons in cost between treatment modalities will be evaluated using a paired t-test where each patient will serve as his or her own control to determine if the cost of frameless fractionated stereotactic radiation therapy (FFSRT) is comparable to standard treatment.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with 1-4 metastatic brain lesions who are considered eligible for single-fraction, frame-based SRS, who are unable or unwilling to undergo frame-based SRS One to 4 untreated metastatic brain lesions Each brain lesion must be less than or equal to 5 cm in diameter and not an optimal surgical candidate Patient must be able have a magnetic resonance imaging (MRI) of the brain for treatment planning Histologic confirmation of malignancy For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment Glomerular filtration rate (GFR) adequate for intravenous (IV) contrast delivery for imaging No concurrent chemotherapy Patient may have had prior therapy for brain metastasis, including radiosurgery and surgical resection at the discretion of the treating physician however only new untreated lesions will be followed on protocol. Exclusion Criteria: Five or more metastatic brain lesions Brain lesion(s) greater than 5 cm in diameter Lesion(s) involving the brainstem, optic chiasm or optic nerve(s) Patients unable to have IV contrast for computed tomography (CT) and MRI imaging Patient unable to have an MRI of the brain Patients willing to be treated with frame-based gamma knife SRS at MD Anderson main campus or MD Anderson at the Woodlands Positive pregnant status confirmed by serum or urine pregnancy test Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not optimally treated with SRS Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT Prior whole brain radiotherapy or conventional external beam radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Chun
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
MD Anderson in The Woodlands
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson West Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States

12. IPD Sharing Statement

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Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases

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