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Report for Clinical Trial NCT01731704

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Controlled Study Of Neurocognitive Outcomes In Patients With Five Or More Brain Metastases Treated With Radiosurgery Or Whole-Brain Radiotherapy

This is randomized study of neurocognitive outcomes in patients with five or more brain metastases treated with stereotactic radiosurgery (SRS), specifically the Gamma Knife (GK) system, or whole-brain radiation therapy (WBRT). The primary aim of this study is to compare the change in neurocognitive function outcome between baseline and 6 months in WBRT versus SRS treatment groups.

NCT01731704 Brain Metastases
MeSH:Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms
HPO:Brain neoplasm

2 Interventions

Name: Stereotactic radiosurgery (SRS)

Type: Radiation
Group Labels: 1

Stereotactic Radiosurgery (SRS)

Name: Whole brain radiation therapy (WBRT)

Description: External beam whole-brain radiation therapy 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks
Type: Radiation
Group Labels: 1

Whole Brain Radiation Therapy (WBRT)


Primary Outcomes

Description: All participants will be asked to complete: Online brain function testing: Complete a short 20-minute online brain function (cognitive) assessment every 2 weeks (twice per month, at least 10-14 days apart). Quality of Life Questionnaire: Complete a self-reported (if patient) and caregiver quality of life questionnaires every 10-12 weeks (2.5-3 months). These questionnaires take approximately 15-20 minutes to complete and can be done online or in clinic during follow-up visits.

Measure: To compare the relative change in neurocognitive outcomes (change in oNCF z-score) between baseline and 6 months for surviving patients in upfront WBRT vs. SRS treatment groups.

Time: Every 3 months for 12 months

Secondary Outcomes

Description: Neurocognitive function, 12-months post whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS)specifically the Gamma Knife (GK) system, treatment as measured by the online neurocognitive function (oNCF) composite z-score. Neurocognitive function at all time points as measured by the online neurocognitive function (oNCF) composite z-score.

Measure: To compare the relative change in neurocognitive outcomes (change in oNCF z-score) between baseline and 12 months for surviving patients in upfront WBRT vs. SRS treatment groups.

Time: Every 10-12 weeks for 12 months after treatment

Description: • Quality of life (patient-reported measures) as measured by Beck Depression Inventory, Beck Anxiety Inventory, FACT-Br, FACT-Cog, Fatigue Severity Scale, EuroQol(EQ5D), EORTC-BN20, and QOL-30.

Measure: To compare the relative impact of initial therapy on patients' quality of life (QoL) as measured by caregiver assessments

Time: Every 10-12 weeks for 12 months after treatment

Description: Quality of life as measured by caregiver assessments including Frontal Systems Behavior Scale, Neuropsychiatric Inventory, Functional Activities Questionnaire, and Everyday Cognition Questionnaire.

Measure: To compare the relative impact of initial therapy on patients' quality of life (QoL) as measured by caregiver assessments

Time: Every 10-12 months

Measure: To estimate consistency and change in z-scores for oNCF assessments over all study endpoints in surviving patients treated with upfront whole brain radiation therapy (WBRT) vs. stereotactic radiosurgery (SRS).

Time: Every 10-12 months

Measure: To compare proportions of patients in the two treatment groups that require salvage therapy as a function of systemic disease control (controlled vs. uncontrolled).

Time: 3, 6, 9, and 12 months

Measure: To compare the overall survival between patients in upfront whole brain radiation therapy (WBRT) vs. stereotactic radiosurgery (SRS) treatment groups

Time: baseline to study completion

Other Outcomes

Description: To determine what healthcare cost data can be collected in patients with metastatic disease within a context of a multi-institutional clinical trial.

Measure: Cost analysis

Time: Prior to treatment up to 12 months after treatment is complete

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

The goal of the study is to enroll 120 patients with at least five (≥5) newly-diagnosed brain metastases from non-melanoma, except melanoma patients with BRAF V600E B-Raf protein mutation, primary cancers with the largest intracranial tumor volume ≤10 cc, ≤15 cc total tumor volume, absence of leptomeningeal disease on MRI, and Karnofsky performance status (KPS) score ≥70 (unless due to intracranial disease), and KPS expected to improve to ≥70 with treatment. --- V600E ---



HPO Nodes


HPO: