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Brain Metastases clinical trials

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NCT ID: NCT03550391 Recruiting - Brain Metastases Clinical Trials

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

Start date: November 22, 2018
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03525301 Recruiting - Brain Metastases Clinical Trials

Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors

NCT ID: NCT03520829 Recruiting - Brain Metastases Clinical Trials

Protocol for Evaluating a Planning Algorithm for Gamma Knife Radiosurgery

SPEED
Start date: January 10, 2018
Phase:
Study type: Observational

The process of developing Gamma Knife radiosurgery treatment plans is today very dependent on the level of human expertise resulting in a great heterogeneity of the intrinsic qualities of the treatment planning and the quality of care delivered in radiosurgery. The existing reverse planning systems, although they have progressed considerably in recent years, produce results that are still lower than those achieved by an expert. Conventionally, an experienced dosimetric planner will act mainly on the coordinates of the position of the isocenters, on the size of the collimators, sector by sector, and on the irradiation time of each isocenters. In theory, the combination of these variables provides access to billions of combinatorics whose diversity far exceeds the computational capabilities of the human mind. The dosimetric planner therefore uses a very small part of the spectrum of possible patterns by always reproducing a limited number of empirical solutions. The company Intuitive Therapeutics has developed a new mathematical algorithm which can automatically test in a very short time all the combinatorial possibilities and converge very quickly to the solution that best meets the clinical, anatomical and dosimetric objectives defined by the neurosurgeon. The quick processing of the system also allows the operator to modify the constraints to refine the proposed result in real time. The demonstration of the reality of the performances of this algorithm would give the ability to even inexperienced users to develop high performance planning for the benefit of the patient in terms of optimizing the efficacy / toxicity ratio of the radiosurgery treatment results The primary objective is to evaluate comparatively the quality of the schedules produced by the algorithm developed by the company Innovative Therapeutics to those produced by an expert who carried out more than 15000 dosimetric plannings and radiosurgical interventions. The main criterion of comparison is the Paddick index. The secondary criteria for comparison are: - Compliance index - selectivity index - Gradient index - Maximum, minimum, average dose at risk structures - Dose distribution in the target volume - Treatment time (at equal source activity) - Time of realization of the planning It was chosen to treat patients with vestibular Schwannoma OR multiple brain metastases (> 5) treated in single session by Gamma Knife OR para-optic meningioma in hypo-fractionated treatment on Gamma Knife with restraint mask with inclusion of visual paths in the target volume planning. The aim of the study is to show at least the non-inferiority of this new method compared to the expert user based on the Paddick Index. This index has continuous values between 0 and 1, 0 being the worst case and 1 being the ideal solution. In order to define the sample size needed for each pathology, a pilot phase is required. This phase can be performed retrospectively using treatments already defined by the expert user. This pilot phase will allow us to identify the difference that can be expected between the index values and the variability of this difference. Based on these values we will be able to determine the size of the sample allowing us to statistically test the non-inferiority, or even the superiority of this new device. The number of cases to be included during the pilot phase should be at least ten cases and a maximum of thirty cases. The choice of the number of cases to be integrated during this pilot phase will depend on the homogeneity of the differences obtained on the first cases. These values will allow us to calculate the size of the samples necessary for the study of non-inferiority as well as for the study of superiority. Depending on the calculated sizes samples we will make a choice to ensure that this study takes place in the expected duration.

NCT ID: NCT03508752 Recruiting - Brain Metastases Clinical Trials

Neurocognitive Decline in Patients With Brain Metastases

Start date: December 5, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The phase I component of the study is to identify maximal tolerated dose (MTD). The phase II is to evaluate neurocognitive decline.

NCT ID: NCT03488472 Terminated - Clinical trials for Small Cell Lung Cancer

Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain

RAD 1704
Start date: August 9, 2019
Phase: N/A
Study type: Interventional

This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC).

NCT ID: NCT03458455 Active, not recruiting - Brain Metastases Clinical Trials

Improved Therapy Response Assessment in Metastatic Brain Tumors

TREATMENT
Start date: March 1, 2013
Phase:
Study type: Observational [Patient Registry]

TREATMENT is an observational study addressing the need for knowledge and adequate diagnostic biomarkers in the response assessment of patients with brain metastasis. Reliable response assessment will be highly relevant in the coming years given the introduction of next-generation cancer drugs, including immunotherapy. This project uses advanced Magnetic Resonance Imaging (MRI) and Vessel Architecture Imaging (VAI) to better understand the response to traditional stereotactic radiosurgery (SRS) and immunotherapy. Secondary objectives include: In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to reveal parameters of traditional, immunotherapeutic, and anti-angiogenic therapy response. In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to compare results with traditional biomarkers. Use existing infrastructure at Oslo University Hospital to standardize therapy monitoring. In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to separate real tumor progression from treatment-induced pseudoprogression or radionecrosis In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to assess whether anti-angiogenic drugs improve delivery of chemotherapy.

NCT ID: NCT03449238 Recruiting - Clinical trials for Metastatic Breast Cancer

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Start date: November 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with metastatic breast cancer with at least 2 brain metastases will receive pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of the brain lesions. Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.

NCT ID: NCT03430947 Terminated - Brain Metastases Clinical Trials

Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases

RadioCoBRIM
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

This is a phase II, open label, non-randomised study of vemurafenib and cobimetinib after radiosurgery in adult patients with BRAFV600-mutant melanoma brain metastases. All patients will receive vemurafenib 960 mg twice a day on days 1 - 28 combined with cobimetinib 60 mg once a day on days 1 - 21 of each 28-day treatment cycle until disease progression, drug toxicity or death. The primary objective of this study is to determine the best overall response rate (BORR) in the brain. The extracranial BORR, intra- and extracranial duration of response, progression-free survival and overall survival, adverse events, quality of life and radiomics features predicting long-term local control of brain metastases and treatment-related toxicity will also be examined.

NCT ID: NCT03414944 Recruiting - Brain Metastases Clinical Trials

Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases

SMART-Brain
Start date: December 2, 2016
Phase: N/A
Study type: Interventional

Brain metastases are the most common intracranial tumors in adults. Whole-brain radiation therapy (WBI) increases the median survival of patients with brain metastases up to 3-6 months, but WBI can lead to the decline of cognition and quality of life, with short local control time. The use of SIB(simultaneous integrated boost) technology can increase the local control rate. Hippocampus avoidance can effectively reduce the cognitive impairment caused by WBI.This study was designed to evaluate the safety and efficacy of selective brain radiotherapy (EBI)(based on SIB and hippocampus, inner ear avoidance )in NSCLCs with limited brain metastases.

NCT ID: NCT03412812 Active, not recruiting - Brain Metastases Clinical Trials

A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases

RAD1705
Start date: July 30, 2018
Phase: N/A
Study type: Interventional

This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.