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Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02798029
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain Radiation: Frameless Fractionated Stereotactic Radiation Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Efficacy, Safety, and Cost of Frameless Fractionated Stereotactic Radiation for Parenchymal Brain Metastases
Actual Study Start Date : August 8, 2016
Estimated Primary Completion Date : August 8, 2020
Estimated Study Completion Date : August 8, 2020

Arm Intervention/treatment
Experimental: Treatment (FFSRT)
Patients undergo FFSRT daily over 30 minutes for 3-5 days.
Radiation: Frameless Fractionated Stereotactic Radiation Therapy
Undergo FFSRT
Other Names:
  • FFSRT
  • Frameless SRT
  • FSRS




Primary Outcome Measures :
  1. Incidence of lesion failure based on imagining assessments for each lesion [ Time Frame: Up to 1 year ]
  2. Rates of local control [ Time Frame: Up to 1 year ]
  3. Intracranial progression free survival (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 ]
    Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial PFS.

  4. Overall survival (OS) [ Time Frame: Up to 1 year ]
    Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial OS.

  5. Cost data [ Time Frame: Up to 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798029


Contacts
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Contact: Amit Garg 713-563-2300 agarg@mdanderson.org

Locations
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United States, New Mexico
Presbyterian Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Amit K. Garg    713-563-2300      
Principal Investigator: Amit K. Garg         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Amit K. Garg    713-563-2300      
Principal Investigator: Amit K. Garg         
MD Anderson in Katy Recruiting
Houston, Texas, United States, 77094
Contact: Shalin J. Shah       sjshah@mdanderson.org   
Principal Investigator: Shalin J. Shah         
MD Anderson in The Woodlands Recruiting
The Woodlands, Texas, United States, 77384
Contact: Shalin J. Shah       sjshah@mdanderson.org   
Principal Investigator: Shalin J. Shah         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amit K Garg M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02798029    
Other Study ID Numbers: 2015-0874
NCI-2016-01180 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0874 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms