Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain

Status Recruiting

Clinical Trial Summary

Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain. Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms. Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.

Clinical Trial Description

The purpose of this research study is to compare the effects (good or bad) of receiving stereotactic radiosurgery (SRS) versus receiving hippocampal-avoidant whole brain radiotherapy (HA-WBRT) plus a drug called memantine, on brain metastases. Receiving SRS could control cancer that has spread to the brain. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the stereotactic radiosurgery (SRS) helps to either slow the growth of cancer or stop it from coming back, compared to the usual approach. Doctors will also look to see if this new approach increases the life span of patients with this type of cancer, and if it helps with quality of life and cancer related symptoms. The usual approach for patients who are not in a study is treatment with whole brain radiation therapy alone (WBRT). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03550391
Study type	Interventional
Source	Canadian Cancer Trials Group
Contact	Chris O'Callaghan
Phone	613-533-6430
Email	cocallaghan@ctg.queensu.ca
Status	Recruiting
Phase	Phase 3
Start date	November 22, 2018
Completion date	December 31, 2027

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04074096` - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis	Phase 2
Recruiting	`NCT04474925` - Pre- Versus Post-operative SRS for Resectable Brain Metastases	Phase 3
Recruiting	`NCT05358340` - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions	N/A
Recruiting	`NCT05559853` - Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Completed	`NCT03189381` - Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases	N/A
Completed	`NCT02082587` - Toronto BNB Pilot Study	N/A
Terminated	`NCT01551680` - A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases	Phase 1
Terminated	`NCT00717275` - Study of Temozolomide to Treat Newly Diagnosed Brain Metastases	Phase 2
Recruiting	`NCT05048212` - A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases	Phase 2
Recruiting	`NCT03714243` - Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases	N/A
Recruiting	`NCT05573815` - Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images	N/A
Recruiting	`NCT04899908` - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases	Phase 2
Completed	`NCT04507217` - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC	Phase 2
Recruiting	`NCT05452005` - Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer	Phase 1
Recruiting	`NCT06457906` - SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC	Phase 3
Completed	`NCT04170777` - Perfexion Registration Using CBCT
Recruiting	`NCT03027544` - Tomotherapy for Refractory Brain Metastases	N/A
Completed	`NCT04178330` - Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases	N/A
Terminated	`NCT02187822` - Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases	Phase 1
Terminated	`NCT00538343` - RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms