Metastatic Malignant Neoplasm in the BrainPhase 2NCT02798029
Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases
A Phase 2 study testing Frameless Fractionated Stereotactic Radiation Therapy in people with Metastatic Malignant Neoplasm in the Brain, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Frameless Fractionated Stereotactic Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Aug 2016to 19 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Presbyterian Hospital
Albuquerque, New Mexico, 87106
MD Anderson in The Woodlands
Conroe, Texas, 77384
M D Anderson Cancer Center
Houston, Texas, 77030
MD Anderson West Houston
Houston, Texas, 77079
About this study
Official title: A Phase II Study of the Efficacy, Safety, and Cost of Frameless Fractionated Stereotactic Radiation for Parenchymal Brain Metastases
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Frameless Fractionated Stereotactic Radiation Therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frameless Fractionated Stereotactic Radiation TherapyRadiation
Also called FFSRT, Frameless SRT, FSRS
| Study group | Role | What they receive |
|---|---|---|
| Treatment (FFSRT) | Experimental | Patients undergo FFSRT daily over 30 minutes for 3-5 days. Receives: Radiation: Frameless Fractionated Stereotactic Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lesion failure based on imagining assessments for each lesion
Measured: Up to 1 year
Rates of local control
Measured: Up to 1 year
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.
Measured: From enrollment to either the first observation of progression disease in the brain or death due to any cause, assessed up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start8 Aug 2016
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the BrainStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Chun, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798029
- Sponsor's protocol ID
- 2015-0874
- Other IDs
- NCI-2016-01180, 2015-0874
- Status last verified
- Apr 2024
- First submitted
- 9 Jun 2016
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Efficacy, Safety, and Cost of Frameless Fractionated Stereotactic Radiation for Parenchymal Brain Metastases
- ClinicalTrials.gov ID
- NCT02798029
- Acronym / sponsor ID
- 2015-0874
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (FFSRT) | Experimental | Radiation: Frameless Fractionated Stereotactic Radiation TherapyPatients undergo FFSRT daily over 30 minutes for 3-5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frameless Fractionated Stereotactic Radiation TherapyAlso: FFSRT, Frameless SRT, FSRS | Radiation | Treatment (FFSRT) |
Primary outcome
Incidence of lesion failure based on imagining assessments for each lesion
Time frame: Up to 1 year
Rates of local control
Time frame: Up to 1 year
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Chun principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Frameless Fractionated Stereotactic Radiation Therapy in people with Metastatic Malignant Neoplasm in the Brain, run by M.D. Anderson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of lesion failure based on imagining assessments for each lesion (time frame: Up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.