Behaviors and Mental Disorders

All Conditions

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Nervous System Diseases

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Cognitive Dysfunction

Meningioma

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

This group will include all patients in the study, regardless of location (frontal or temporal lobe) or surgical approach (endoscopic endonasal or craniotomy). Fifty patients will be included in the cohort

These patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.

Long-term Cognitive testing

Megan Frost, BS

Uchechi Okafor, BS

Daniel Prevdello, MD

Daniel Prevedello, MD

The purpose of this prospectively enrolling trial is to assess long-term cognitive outcomes of patients undergoing surgery for resection of a meningioma associated with the frontal and temporal lobes.

This study will look at patients who are undergoing resection of a skull based meningioma, located in the frontal or temporal lobe, via craniotomy or via endoscopic endonasal approach. The study will compare cognitive function at baseline, at six weeks postoperatively and at one year postoperatively. The cognitive testing being done at baseline will be a clinical care set of assessments done by the speech language pathology team and will include the RBANS tests, the MoCA, PROMIS-29, and NeuroQOL-Cognitive Functions.

Cognitive Status After Removal of Skull Base Meningioma

Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes

There will not be sharing of individual participant data with other researchers

Assessment of preoperative and postoperative comorbidities and their effects on cognitive function post-operatively. Co-morbidities will be based on clinical outcomes evaluated by the primary investigator, co-investigators and the speech language pathology team.

Cognitive function will be compared at baseline and at one year post-operatively.

Patients divided by approach and overall cognitive function will be evaluated.

Patients will be divided by tumor location and cognitive function will be evaluated.

Ohio State University

Clinical Professor

All Drugs and Chemicals

Edotreotide

Treatment Schedule Carbon Ion Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose

Treatment Schedule Proton Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose

Treatment Schedule Photon Radiation 3 Gy E Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose

Treatment Schedule Photon Radiation 1.8 Gy E Total Dose 57.6 Gy Gy E, 32 fractions, 1.8 Gy E single dose

Patients will be immobilized using an individually manufactured head mask for treatment planning and RT. Contrast-enhanced CT as well as MR-imaging will be performed for target volume definition. OAR such as the brain stem, optic nerves, chiasm and spinal chord will be contoured. The fractionation scheme will be taken into account for dose prescription, as well as DVH-characteristics and clinical parameters of the invidivual patient.

The Gross Tumor Volume (GTV) will be defined as the contrast-enhancing lesion on MRI on T1-weighted MR-imaging. Amino-Acid-PET or DOTATOC-PET may be used in addition to contrast-enhanced MRI for target volume definition but is not mandatory.The Clinical Target Volume (CTV) will be defined adding 1-2mm safety margin to the GTV.

Carbon Ion Radiotherapy

As described previously, patients will be immobilized using an individually manufactured head mask for treatment planning and RT. Contrast-enhanced CT as well as MR-imaging will be performed for target volume definition. OAR such as the brain stem, optic nerves, chiasm and spinal chord will be contoured. Dose constraints of normal tissue will be respected according to Emami et al. (33). The fractionation scheme will be taken into account for dose prescription, as well as DVH-characteristics and clinical parameters of the invidivual patient.

The Gross Tumor Volume (GTV) will be defined as the contrast-enhancing lesion on MRI on T1-weighted MR-imaging. Amino-Acid-PET or DOTATOC-PET may be used in addition to contrast-enhanced MRI for target volume definition but is not mandatory.The Clinical Target Volume (CTV) will be defined adding 1-2mm safety margin to the GTV.

Proton Therapy

Treatment Planning for Photon Radiotherapy will be performed using the Planning Systems available at the Department of Radiation Oncology in Heidelberg, Germany (including Masterplan/Nucletron, Virtuos-Konrad/Siemens, or Precisis/STP/Stryker-Leibinger, or the Tomotherapy Software). Carbon ion and proton RT planning is performed using the treatment planning software PT-Planning (Siemens, Erlangen, Germany) including biologic plan optimization. Biologically effective dose distributions will be calculated using the a/ß ratio for meningioma as well as for the endpoint late toxicity to the brain. Patient positioning prior to radiotherapy will be evaluated by comparison of x-rays to the DRRs. Set up deviations \>3mm are corrected prior to radiotherapy.

To the target volume defined for photon treatment, a total dose of 52.2 Gy E - 57.6 Gy E is applied in single fractions of 1.8Gy E. In the 3Gy E Photon arm, photon radiotherapy will be delivered to a total dose of 45 Gy E in 15 fractions.

Hypofractionated Photon Radiotherapy

Treatment Planning for Photon Radiotherapy will be performed using the Planning Systems available at the Department of Radiation Oncology in Heidelberg, Germany (including Masterplan/Nucletron, Virtuos-Konrad/Siemens, or Precisis/STP/Stryker-Leibinger, or the Tomotherapy Software). Carbon ion and proton RT planning is performed using the treatment planning software PT-Planning (Siemens, Erlangen, Germany) including biologic plan optimization. Biologically effective dose distributions will be calculated using the a/ß ratio for meningioma as well as for the endpoint late toxicity to the brain. Patient positioning prior to radiotherapy will be evaluated by comparison of x-rays to the DRRs. Set up deviations \>3mm are corrected prior to radiotherapy.

Conventional Photon Radiotherapy

In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. There will be two treatment arms with photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional fractionation. The study is designed as descriptive study on feasibility of the investigated therapies aiming at a comparison of toxicities. The study will serve as a basis for further larger randomized protocols comparing efficacy of the therapies, assuming toxicity is comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and quality of life.

Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

Randomized Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

Toxicity graded according to CTCAE Version 4.1 after 1 year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cognitive Status After Removal of Skull Base Meningioma	NCT04635657	Meningioma Skull Base Meni... Frontal Meningi... Temporal Mening... Cognitive Impai... Cognitive Decli... Post-Surgical C...	Long-term Cogni...	18 Years - 89 Years	Ohio State University
Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.	NCT01795300	Skull Base Meni...	Carbon Ion Radi... Proton Therapy Hypofractionate... Conventional Ph...	18 Years -	University Hospital Heidelberg

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