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Nervous System Neoplasms

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Quality of Life

Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity

Stereotactic Radiosurgery of the resection cavity (SRS)

IGRT

Gianfranco A Pesce, MD

Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases

Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.

Hypofractionated Brain Radiationcavity

Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial

Evaluate the recurrence probability in the surgical cavity after radiotherapy

The proportion of surviving patients at 1 year

The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria

Time to neurological deterioration (objective neurological examination and MMSE)

Evaluation of the quality of life through questionnaire

Oncology Institute of Southern Switzerland

Tracie Granger

Sarah Fouke, MD

This registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and imaging data (including anatomic and advanced imaging sequences obtained prior to and serially following SRS) will be archived in an online informatics platform, specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for Metastatic Tumors (CONDR - Mets).

Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)

Swedish Medical Center

Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 1: intervention of physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.

Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 2: intervention of both cognitive rehabilitation and physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.

Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: Intervention of cognitive rehabilitation begins prior to and is concurrent with WBRT/SRS treatment. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: continue intervention of cognitive rehabilitation; add intervention of physical activity. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.

* Self-exercise: number of steps per day, per fitness tracker; self-report of daily activity.
* One-to-one intervention: 30 minute sessions with licensed therapist to include warm-up, generalized strengthening, stretching.

Physical Activity

One-to-one intervention: 45 minutes sessions with licensed therapist to include graded cognitive tasks designed to improve executive functioning with focus on both restorative and compensatory approaches.

Cognitive rehabilitation

Suzanne F. Taylor, PhD, MBA, OTR/L

To determine the feasibility of processes and instruments with an overarching purpose to guide the design of a larger study. To determine the feasibility of individuals with metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation (CR) as in an outpatient therapy setting.

Rolling recruitment for the study. Participants will be randomized into one of three treatment arms. All treatment arms will undergo physical \& cognitive testing prior to whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS). Arm 3 will receive cognitive rehabilitation intervention sessions prior to, and concurrent with, WBRT/SRS. Approximately 14 days following WBRT/SRS: all arms will undergo physical and cognitive testing, and: Arm 1 will begin physical activity intervention. Arm 2 will begin physical activity intervention and cognitive intervention. Arm 3 will continue with cognitive intervention and begin physical activity intervention. All Arms will undergo physical and cognitive testing approximately 2.5 months post WBRT/SRS.

All participants will be blinded to the study design and will be randomized into one of three treatment arms. Research assistant is blinded to both the study design and to which arm the participants are randomized.

Impact of Cognitive Rehab and Physical Activity on Cognition in Patients With Metastatic Brain Tumors Undergoing RT

Does Cognitive Rehabilitation and Physical Activity Impact Executive Functioning Following Radiation Therapy for Cerebral Metastases? A Pilot Study

Recruitment: success defined as enrollment rate of 19% of eligible subjects.

Retention: success defined as retention rate above 56% at end-of-study.

Participant missed or cancelled therapy sessions less than 15% of time.

Participant completed full scheduled minutes per session ≥ 80% of time.

Participant completed ≥ 80% of PA interventions (required \< 20% rest period during or between tasks).

Participant completed ≥ 80% of CR interventions (required \< 20% rest period during or between tasks).

Composite score post-CR intervention, minus the composite score at baseline. Scores of zero indicates maintained cognition. Positive scores indicate improved cognition. Negative scores indicate declined cognition. Composite scores derived from the following four standardized tests:

* The Stroop Color Word Test (SCWT) is a 3-part measure that tests the executive function area of attention.
* The Trail Making Test (TMT) is a 2-part measure that tests the executive function area of complex attention.
* The Rey Auditory Verbal Learning Test (AVLT) is a 6-part measure that tests the executive function area of memory.
* The Clock Drawing Test (CDT) is a single measure that tests the executive function area of visuospatial relationships and praxis.

Composite scores post intervention minus scores at baseline. Scores of zero indicate maintained physical abilities. Positive scores indicate improved physical abilities. Negative scores indicate declined physical abilities. Composite scores derived from the following two standardized tests:

* The Timed Up and Go (TUG) is a single measure that tests mobility, balance, and walking ability.
* The 30-second Chair Stand Test (30sCST) is a single measure that tests functional lower body strength.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Brain Radiationcavity	NCT03561896	Brain Metastase... Cancer Brain	IGRT SRS	18 Years -	Oncology Institute of Southern Switzerland
Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)	NCT01908179	Metastatic Brai...		19 Years - 80 Years	Swedish Medical Center
Hypofractionated Brain Radiationcavity	NCT03561896	Brain Metastase... Cancer Brain	IGRT SRS	18 Years -	Oncology Institute of Southern Switzerland
Impact of Cognitive Rehab and Physical Activity on Cognition in Patients With Metastatic Brain Tumors Undergoing RT	NCT03096431	Metastatic Brai... Cerebral Metast...	Physical Activi... Cognitive rehab...	18 Years -	Virginia Commonwealth University

Spots Global Cancer Trial Database for sterotactic radiosurgery