SIMT Stereotactic Radiosurgery Outcomes Study

NCT02886572 | Completed Results

• 1 other identifier: Pro00075429
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effectiveness and efficiency of Single Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more brain metastases

Conditions

Brain Metastases, Adult

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score

  Calculated from the time of protocol Stereotactic RadioSurgery (SRS). The GPA incorporates four factors: age, KPS (Karnofsky Performance Score), ECM (extracranial metastases) and number of BM (brain metastases). Each factor is given a score of 0, 0.5 or 1.0 and GPA is calculated as a sum score of all four factors. The GPA has four groups: the GPA 0-1 with median survival of 2.6 months; GPA 1.5-2.5 with survival of 3.8 months; GPA 3 with median survival of 6.9 months and GPA 3.5-4.0 with the best median survival of 11 months.

  Up to 24 months after SRS

Secondary Outcomes (4)

• Number of Participants Who Experience Local Brain Recurrence Within 1 Year of SIMT SRS Treatment

  Up to 12 months after SRS

• Number of Participants Who Are Dead Within 1 Year of SIMT SRS Treatment Due to Neurologic Reasons

  Up to 12 months after SRS

• Number of Participants Who Experience a New Brain Metastasis at a Site Different From the Original Brain Metastasis Site 1 Year After SIMT SRS Treatment

  Up to 12 months after SRS

• Number of Participants Who Experience Grade 3, 4, or 5 Neurologic Adverse Events Attributable to SIMT SRS

  Up to 12 months after SRS

Study Arms (1)

Stereotactic Radiosurgery

EXPERIMENTAL

All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014

Radiation: Stereotactic radiosurgery

Interventions

Stereotactic radiosurgery RADIATION

Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery

Also known as: SRS

Stereotactic Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A contrast-enhanced MRI scan showing = or \> 4 brain metastases.
• Age \>/=18 years of age.
• KPS \>/= 70
• Patient must have a graded prosnostic score (GPA) score 0.5 or greater
• Life expectancy of at least 3 months
• Postoperative patients with resected brain metastases are eligible.
• Largest lesion \< 4cm diameter
• Must be a candidate for MRI imaging
• Previous cranial stereotactic radiosurgery (SRS) or whole brain radiation therapy (WBRT) is allowed if \> 3 months prior to SIMT
• Must be capable of providing informed consent

You may not qualify if:

• Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
• Metastases within 2 mm of the optic apparatus
• Patients unable to obtain MRI
• Evidence of leptomeningeal disease
• Greater than 10 brain metastases
• Pregnant women are excluded

Sponsors & Collaborators

• Duke University: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Kim GJ, Buckley ED, Herndon JE, Allen KJ, Dale TS, Adamson JD, Lay L, Giles WM, Rodrigues AE, Wang Z, Kelsey CR, Torok JA Jr, Chino JP, Fecci PE, Sampson JH, Anders CK, Floyd SR, Yin FF, Kirkpatrick JP. Outcomes in Patients With 4 to 10 Brain Metastases Treated With Dose-Adapted Single-Isocenter Multitarget Stereotactic Radiosurgery: A Prospective Study. Adv Radiat Oncol. 2021 Jul 23;6(6):100760. doi: 10.1016/j.adro.2021.100760. eCollection 2021 Nov-Dec.

  PMID: 34934856 RESULT

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Joan Cahill BNS OCN CCRP
• Organization: Duke University Health System

joan.cahill@duke.edu

(919) 668-5211

Study Officials

• Grace J. Kim, MD PhD

  Duke University Medical Center, Radiation Onoclogy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: January 25, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 1, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)