Metastatic CancerPhase 2NCT00814463
Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases
A Phase 2 study testing MMSE, QOL via FACT-Br and MRI in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University at 1 site in United States.
Trial summary
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- MMSE, QOL via FACT-Br and MRI
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age >18 years of age.
- Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
- Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.
- Life expectancy of at least 3 months.
Who cannot join
- Radiographic or cytologic evidence of leptomeningeal disease.
- Patient with incomplete or partial resection.
- Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
- Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted MRI scan.
- Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
- Pregnant or need to breast feed during the study period.
Show all 10Show fewer
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
- Brain surgery other than for resection of metastasis.
- Previous brain radiotherapy.
- Contraindication to SRS, WBRT, or MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
Read the detailed description
OBJECTIVES:
Primary
- To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT).
Secondary
- To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone.
- To estimate the rate of new brain metastases outside of the adjuvant SRS site.
- To estimate patient quality of life after adjuvant SRS alone.
- To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients.
- To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients.
- To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease.
- To estimate the overall survival of these patients.
OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes.
Quality of life and neurocognitive function are assessed periodically.
After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
- Being tested
- MMSE, QOL via FACT-Br, MRI, Post-operative SRS
- Keywords
- tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSEBehavioural
Also called Mini-Mental Status Exam
Neurocognitive function via MMSE done every 3 months for length of study.
QOL via FACT-BrBehavioural
Also called Quality of Life, Functional Assessment of Cancer Therapy - Brain
Quality of Life via FACT-BR every 3 months for length of study.
MRIProcedure or surgery
Also called Magnetic Resonance Imagine
MRI done every 3 months for the length of the study.
Post-operative SRSRadiation
Also called SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
| Study group | Role | What they receive |
|---|---|---|
| Post-operative SRS | Active comparator | All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. Receives: Behavioral: MMSE; Behavioral: QOL via FACT-Br; Procedure: MRI; Radiation: Post-operative SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate at the Surgical Site as Measured by MRI
The number of months for local recurrence via MRI
Measured: 12 months
Secondary outcomes (7)
Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Measured: 12 months
Rate of New Brain Metastases Outside of the Adjuvant SRS Site
Measured: 12 months
Quality of Life as Measured by the FACT-Br Subscales
Measured: Every 3 months for 12 months
Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam
Measured: Every 3 months for 12 months.
Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)
Measured: 12 months
Rate of Death Due to Neurologic Causes
Measured: 12 months
Overall Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Early analysis indicated SRS not as beneficial post-op as pre-op
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John H. Sampson, MD, PhD, Principal investigator, Duke UniversityHamidreza Aliabadi, MD, Principal investigator, Duke UniversityJohn P. Kirkpatrick, MD, Principal investigator, Duke UniversityJames E. Herndon, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814463
- Sponsor's protocol ID
- Pro00004373
- Other IDs
- DUMC-PRO00004373, CDR0000630239
- Status last verified
- Feb 2019
- First submitted
- 23 Dec 2008
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
- ClinicalTrials.gov ID
- NCT00814463
- Acronym / sponsor ID
- Pro00004373
- Keywords
- tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early analysis indicated SRS not as beneficial post-op as pre-op
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Dec 2008 (estimated)
- Results
- Posted 7 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
Detailed description
OBJECTIVES:
Primary
- To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT).
Secondary
- To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone.
- To estimate the rate of new brain metastases outside of the adjuvant SRS site.
- To estimate patient quality of life after adjuvant SRS alone.
- To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients.
- To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients.
- To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease.
- To estimate the overall survival of these patients.
OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes.
Quality of life and neurocognitive function are assessed periodically.
After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 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 |
|---|---|---|
| Post-operative SRS | Active comparator | Behavioral: MMSE, Behavioral: QOL via FACT-Br, Procedure: MRI, Radiation: Post-operative SRSAll patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years of age.
- Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
- Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.
- Life expectancy of at least 3 months.
Key exclusion criteria (10 listed)
- Radiographic or cytologic evidence of leptomeningeal disease.
- Patient with incomplete or partial resection.
- Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
- Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted MRI scan.
- Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
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 |
|---|---|---|
| MMSEAlso: Mini-Mental Status ExamNeurocognitive function via MMSE done every 3 months for length of study. | Behavioural | Post-operative SRS |
| QOL via FACT-BrAlso: Quality of Life, Functional Assessment of Cancer Therapy - BrainQuality of Life via FACT-BR every 3 months for length of study. | Behavioural | Post-operative SRS |
| MRIAlso: Magnetic Resonance ImagineMRI done every 3 months for the length of the study. | Procedure or surgery | Post-operative SRS |
| Post-operative SRSAlso: SRSSingle fraction SRS is currently a viable treatment option of intracranial metastatic lesions. | Radiation | Post-operative SRS |
Primary outcome
Recurrence Rate at the Surgical Site as Measured by MRI
Time frame: 12 months
The number of months for local recurrence via MRI
7 secondary outcomes
Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Time frame: 12 months
Rate of New Brain Metastases Outside of the Adjuvant SRS Site
Time frame: 12 months
Quality of Life as Measured by the FACT-Br Subscales
Time frame: Every 3 months for 12 months
Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam
Time frame: Every 3 months for 12 months.
Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)
Time frame: 12 months
Rate of Death Due to Neurologic Causes
Time frame: 12 months
Overall Survival
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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.
John H. Sampson, MD, PhD principal investigator
Duke University
Hamidreza Aliabadi, MD principal investigator
Duke University
John P. Kirkpatrick, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MMSE, QOL via FACT-Br and MRI in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University at 1 site 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 4 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: stopped early, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 7 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recurrence Rate at the Surgical Site as Measured by MRI (time frame: 12 months). 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 26 Feb 2019.