Neoplasms

Nervous System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Meningioma

Solitary Fibrous Tumors

Hemangiopericytoma

Neoplasms, Fibrous Tissue

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

All Drugs and Chemicals

Imidacloprid

Protons have been demonstrated for medulloblastoma and prostate cancer, and comparative treatment planning using protons versus photons have shown a clear advantage to protons in terms of dose distribution.

Proton Radiation

This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III Meningioma \& Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy. The study will be performed in two phases: first, feasibility with an enrollment of 12 patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients. All patients will also be given quality of life (QOL) instruments pretreatment, weekly during treatment, then q 3 months for year 1 post treatment, q6 months year 2 \& 3 and yearly for year 4 \& 5. Comparisons will be made between the enrolled subjects receiving proton therapy and the known literature on photon radiation. See section 2 for full objectives. The second phase will begin no earlier than 60 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Primary Objectives:

The primary objectives of this study are feasibility and safety. The study will be deemed infeasible if greater than 10% of pts experience one of the following:

* Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.

  (95% of target volume covered by 95% of the dose)
* Patient is unable to tolerate 20% of treatments (for any reason unable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using proton radiotherapy (up to 80% of treatments could be delivered using photons).
* Patient is unable to complete all of his/her treatments within 7 days of estimated date of treatment completion or requires a treatment break greater than 5 days. Toxicity will be deemed unacceptable if greater than 20% of patients experience acute toxicity, as defined in Section 7.12.

Secondary Objectives:

* To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas.
* To assess quality of life outcomes, with a focus on the rate of severe fatigue at 6 and 12 months from end of treatment.
* To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas.
* To compare the dose distribution to tumor and surrounding normal structures using DVHs (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
* To determine 1-yr local control and progression-free and overall survival using proton radiotherapy.

Proton Radiation For Meningiomas and Hemangiopericytomas

Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas

For proton to deemed feasible, no greater than 10% of patients should experience a) Patient cannot be given treatment because anatomy is such that a dosimetically satisfactory treatment plan cannot be devised, b) Patient is unable to tolerate 20% of treatments using proton therapy, and c) patient is unable to complete all treatments within 7 days of estimated date of treatment completion

Late toxicity is defined as any grade 3 or higher toxicity, excluding seizures, observed later than 90 days from start of radiation therapy.

Fatigue will be scored by the Brief Fatigue Inventory (BFI), a validated instrument, which will be evaluated at the following time points: Pre-radiation, weekly during treatment, at 3, 6, 9, 12 months post-radiation and then every 6 months. It is expected that BFI score will increase (as fatigue worsens) in the first 6-9 months post-radiation and then the BFI score will decrease (as fatigue improves) at 12-24 months post-radiation. Proton radiotherapy is expected to improve fatigue as compared to photon radiotherapy.

Health Related Quality of Life will be followed using the following: EQ-5D European Quality of Life Index, Fact-G Functional Assessment of Cancer Therapy-General (FACT-G), and Fact-BR Functional Assessment of Cancer Therapy-Brain. Fact-BR will be evaluated at the same time points as the BFI. EQ-5D and Fact-G will be evaluated at pre-radiation, at 3, 6, 9, 12 months postradiation and then every 6 months.

Cumulative total dose (Gy) to normal brain tissue will be estimated based on dosimetry plans for both proton and photon. Proton radiotherapy is expected to decrease exposure to normal brain tissues.

PFS and OS are defined as the time from start of radiotherapy to first documented progression (event for PFS), death due to any cause or last patient contact alive.

Abramson Cancer Center at Penn Medicine

Glioma

Brain Neoplasms

Pinealoma

Ependymoma

Hemangioblastoma

Choroid Plexus Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Brain Diseases

Central Nervous System Diseases

Cerebral Ventricle Neoplasms

Hemangioma

Hemangioma, Capillary

Germ Cells Tumors

Pineocytoma

Neuroepithelioma

The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.

Observational

EORTC HQ

Jordi Bruna Escuder

Michael Weller

Every new classification depends on its prognostic power and on the type of treatment given. With the rapid evolution of diagnostic methods and the advance in new treatments, there is much less reliable information available on how patients with newly defined brain tumour entities should be treated and what to expect from the current treatments.

The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.

* Tumour tissue specifically stored for the purpose of this project
* Residual biological material ("leftovers") and/or derivatives

Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification

Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Diagnosed According to cIMPACT-NOW Recommendations and the 2021 WHO Classification

Date of surgery that allowed for the first pathological diagnosis up to the date of death (any cause). Patients will be followed up for 5 years after enrolment.

From the date of start of the anti-tumor therapy until the date of first objective progression as determined by the local investigator or the date of patient's death whichever occurs first. Patients will be followed up for 5 years after enrolment.

Recorded from the date start of an anti-tumor therapy until disease progression or start of a new anti-tumor therapy. Patients will be followed up for 5 years after enrolment.

European Organisation for Research and Treatment of Cancer - EORTC

Musculoskeletal Diseases

Eye Diseases

Adenoma

Neurilemmoma

Germinoma

Astrocytoma

Craniopharyngioma

Adamantinoma

Nerve Sheath Neoplasms

Oligodendroglioma

Optic Nerve Glioma

Ganglioglioma

Ameloblastoma

Bone Neoplasms

Bone Diseases

Optic Nerve Neoplasms

Peripheral Nervous System Neoplasms

Cranial Nerve Diseases

Optic Nerve Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neuroendocrine Tumors

Neuroma

Schwannoma

Central Nervous System Germinoma

Neuroendocrine Tumor

The participants are seen at the outpatient clinic by a physician, physician assistant or trial nurse at standard follow-up times at 2.5, 5, 7.5 and 10 years after radiotherapy.

ProTRAIT

Danielle Eekers

Hiske van der Weide

Inge Compter

Yvonne Klaver

Jaap Zindler

Miranda Kramer

M Kramer

M Kroesen

A Mendez Romero

J Jaspers

I Coremans

The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.

Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Time to neurocognitive failure, defined as the time from last radiotherapeutic treatment to the first instance of a measured HVLT-dr of -1.5Z based on the normal data

HVLT- delayed recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

HVLT total recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

TMT a decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

TMT b decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

COWA total decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

University Medical Center Groningen

HollandPTC

Erasmus Medical Center

Leiden University Medical Center

Medical Center Haaglanden

Maastro Clinic, The Netherlands

Maastricht Radiation Oncology

Antineoplastic Agents

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

IV Pembrolizumab 200mg, given every 3 weeks until disease progression or intolerable toxicity

Dror Limon, Dr

Shlomit Yust-Katz, Dr

Shlomit Yust-Katz, MD

Dror Limon, MD

A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma

This is a multicenter, prospective, single arm, open label, interventional study. The goal of this study, is to evaluate feasibility and efficacy of pembrolizumab for the treatment of recurrent or progressive meningioma (WHO grades II-III) or hemangiopericytoma (HPC). All patients will receive IV pembrolizumab, at a dose of 200mg, every 3 weeks. Patients will be treated until disease progression or intolerable toxicity. Treatment can be stopped after one year of treatment in case of stable disease or completer response, with re-initiation of treatment upon progression. Expression of PD1 and PD-L1 will be tested, on tumor cells, using IHC staining on biopsy material obtained from previous surgeries.

All patients will have a baseline neurologic and clinical exam, MRI scan, a brain dedicated CT-PET scan, a baseline cognitive exam and QOL assessment with a dedicated questionnaire. Patients will have a clinical and neurological exam every treatment cycle. MRI scan will be repeated after 2 months from the beginning of the trial drug administration and then every 2-3 months. There are no designated and specific criteria for response assessment in the treatment of meningioma. Therefore, response evaluation will be made using the RECIST 1.1 criteria, as used for solid tumors. The trial will allow the continuation of pembrolizumab in case of stable or improved clinical response, when pseudo-progression is suspected in the MRI. In addition, response assessment will also be made according to the RANO criteria, as used for high grade glioma. This will be compared to the RECIST evaluation, but will not be used for treatment decision making.

A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma

To determine the 6 months progression free survival (PFS) rate for patients with recurrent or progressive meningioma on pembrolizumab therapy, using the RECIST 1.1 criteria.

To determine the 12 months progression free survival (PFS) rate for patients with recurrent or progressive meningioma on pembrolizumab therapy, using the RECIST 1.1 criteria.

To determine OS of patients with recurrent or progressive meningioma treated with pembrolizumab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proton Radiation For Meningiomas and Hemangiopericytomas	NCT01117844	Meningioma Hemangiopericyt...	Proton Radiatio...	18 Years -	Abramson Cancer Center at Penn Medicine
Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification	NCT05259605	Glioma Glioneuronal Tu... Choroid Plexus ... Pineal Tumors Germ Cell Tumor Tumor of the Se... Diffuse Midline... Ependymoma Embryonal Tumor Pineal Tumor Hemangiopericyt... Hemangioblastom... Melanocytic Tum...	Observational	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology	NCT04648462	Astrocytoma Ependymoma Ganglioglioma Oligodendroglio... Optic Nerve Gli... Meningioma Nerve Sheath Ne... Adenoma Craniopharyngio... Hemangiopericyt... Germinoma Neurilemmoma	ProTRAIT	18 Years -	Maastricht Radiation Oncology
Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification	NCT05259605	Glioma Glioneuronal Tu... Choroid Plexus ... Pineal Tumors Germ Cell Tumor Tumor of the Se... Diffuse Midline... Ependymoma Embryonal Tumor Pineal Tumor Hemangiopericyt... Hemangioblastom... Melanocytic Tum...	Observational	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Proton Radiation For Meningiomas and Hemangiopericytomas	NCT01117844	Meningioma Hemangiopericyt...	Proton Radiatio...	18 Years -	Abramson Cancer Center at Penn Medicine
A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma	NCT03016091	Atypical Mening... Anaplastic Meni... Hemangiopericyt...	Pembrolizumab	18 Years -	Rabin Medical Center
Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology	NCT04648462	Astrocytoma Ependymoma Ganglioglioma Oligodendroglio... Optic Nerve Gli... Meningioma Nerve Sheath Ne... Adenoma Craniopharyngio... Hemangiopericyt... Germinoma Neurilemmoma	ProTRAIT	18 Years -	Maastricht Radiation Oncology

Spots Global Cancer Trial Database for hemangiopericytoma