Neurocognitive Decline in Patients With Brain Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03508752|
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: Stereotactic Radiosurgery||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial to Determine the Neurocognitive Decline in Patients With Multiple (>6) Brain Metastases Treated With Distributed Stereotactic Radiosurgery|
|Actual Study Start Date :||December 5, 2017|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Radiation: Stereotactic Radiosurgery
Stereotactic Radiosurgery dose is based on the largest tumor size
- Phase I: To determine the toxicity within 60 days from the date of SRS, in patients with a greater intracranial disease burden, defined as 6 or more metastases. [ Time Frame: 60 days ]
Any subject who receives treatment on this protocol will be evaluated for toxicity. Each patient will be assessed for the development of toxicity according to the study calendar. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
The following acute (<30 days) and subacute (>30 days - <60 days) toxicities probably or definitely attributable to the protocol treatment, as defined in CTCAE v4.0, will be dose limiting toxicities (DLT) of the study.
Grade 3 or higher neurologic toxicity in the below categories:
- Symptomatic Central Nervous System Necrosis which is interfering with ADLs, or requiring treatment with hyperbaric oxygen, Avastin, or resection. Asymptomatic necrosis present on imaging alone does not constitute DLT.
- Cerebral Edema (Grade 4)
- Intracranial Hemorrhage
Any Grade 4 or 5 toxicities definitely attributable to the protocol treatment.
- Phase II: Determine the cognitive deterioration (HVLT delayed recall) in patients treated with SRS for multiple metastases (from baseline to 4 months) [ Time Frame: 4 months ]
The Hopkins Verbal Learning Test (HVLT) is a memory test that gives information about memory.
Each patient will serve as her or his own control, and the relative decline in HVLT-DR score from baseline to 4 month follow-up is deﬁned as
Δ HVLT-DR = (HVLT-R DR at baseline - HVLT-DR at 4 month follow up) / HVLT-DR at baseline.
A positive change indicates a decline in function.
- To determine the optimal dose which will provide local control in patients with a greater intracranial disease burden, defined as 6 or more metastases [ Time Frame: 90 days ]It is assumed that the optimal dose will be the maximum tolerated dose. However, the maximum tolerated dose may or may not be the most ideal dose balancing benefit and toxicity with the widest therapeutic window.
- To determine neurocognitive outcomes [ Time Frame: 3 years ]via HVLT and quality of life via FACT-Br amongst patients treated with > 6 metastases via SRS.
- To detemine overall survival [ Time Frame: 2 years ]overall survival (OS) is defined as the time between date of SRS and date of death
- To determine the time to distant brain recurrence [ Time Frame: 3 years ]distant brain recurrence is defined as time between date of SRS and development of new metastases
- To determine the incidence of salvage WBRT or radiosurgery [ Time Frame: 4 months ]WBRT is defined as whole brain radiation therapy
- To determine the incidence of development of leptomeningeal disease [ Time Frame: 2 years ]Leptomeningeal disease is an exclusion criteria for the study
- To prospectively collect treatment time of patients treated for multiple metastases [ Time Frame: 2 years ]reported in a routine manner at scheduled times during the trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508752
|Contact: Zabi Wardak, MD||214-685-8525||Zabi.firstname.lastname@example.org|
|Contact: Kamaryn Keeton||214/648-5779||Kamaryn.Keeton@UTSouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Kamaryn Keeton 214-648-5779|
|Principal Investigator:||Zabi Wardak, MD||UT Southwestern Medical Center|