Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The trial evaluates the effect of a moderately increased radiation dose in patients with atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery. Endpoint is recurrence-free survival after 5 years.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma

NCT00626730

Brain and Central Nervous System Tumors

UNKNOWN PHASE2

Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT02179086

Glioblastoma

ACTIVE_NOT_RECRUITING PHASE2

Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide

NCT00717210

Anaplastic Astrocytoma Oligodendroglioma Oligoastrocytoma

COMPLETED PHASE3

Carbon Ion Radiotherapy for Atypical Meningiomas

NCT01166321

Meningioma

ACTIVE_NOT_RECRUITING NA

PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas

NCT05190172

Oligodendroglioma Oligodendroglioma, Anaplastic Diffuse Astrocytoma, IDH-Mutant

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The trial intends to optimize treatment for grade II and grade III (atypical or anaplastic) meningioma. Standard treatment for atypical or anaplastic meningioma is surgery. For grade III (anaplastic) meningiomas, post-operative radiotherapy would be performed in all cases using standard fractionation schedules to a total dose of \~60 Gy. For grade II (atypical) meningiomas, although some small patient datasets support early onset of radiotherapy, the standard treatment is still to irradiate if tumours are recurrent or if resection was macroscopically incomplete. Total doses of 54 to \~60 Gy are applied using standard fractionation schedules.

A major problem of the treatment of atypical or anaplastic meningioma is that beyond surgery and radiotherapy, there are only experimental treatment options and the probability of local recurrences is 50-100% within the first 5 years for grade II and grade III meningioma.

The present trial has been developed to evaluate efficacy of a dose-intensified radiotherapy treatment schedule for incompletely or not resected meningioma to a total dose of 68 (grade II) or 72 Gy (grade III). To minimize normal tissue toxicity, the boost dose or the complete radiotherapy is applied using protons. The expectation is a higher recurrence-free survival compared to previous reports on outcome of standard dose (60 Gy) radiotherapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Grade II tumors (macroscopic)

Radiotherapy 68 Gy(RBE)

Group Type EXPERIMENTAL

Radiotherapy 68 Gy(RBE)

Intervention Type RADIATION

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton

Grade III tumors (macroscopic)

Radiotherapy 72 Gy(RBE)

Group Type EXPERIMENTAL

Radiotherapy 72 Gy(RBE)

Intervention Type RADIATION

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton and boost 2 to 4 Gy(RBE) proton

Grade II/III tumors (completely resected)

Radiotherapy 60 Gy(RBE)

Group Type ACTIVE_COMPARATOR

Radiotherapy 60 Gy(RBE)

Intervention Type RADIATION

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiotherapy 68 Gy(RBE)

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton

Intervention Type RADIATION

Radiotherapy 72 Gy(RBE)

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton and boost 2 to 4 Gy(RBE) proton

Intervention Type RADIATION

Radiotherapy 60 Gy(RBE)

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* histologically confirmed atypical (WHO grade II) or anaplastic (WHO grade III) meningioma with the indication for radiotherapy
* MRI (within 24h post-operative, if not available than with a time interval of \~ 6 weeks) including contrast-enhanced T1 weighted 3D dataset and PET for evaluation of macroscopic tumour (residuum)
* Karnofsky Performance Score ≥ 60, ECOG ≤2
* For women with childbearing potential, (and men) adequate contraception.
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

* refusal of the patients to take part in the study
* previous radiotherapy of the brain
* several manifestations of the meningioma in different regions of the brain or additional spinal manifestations
* distant metastases
* patients who are not suitable for radiotherapy
* known other malignant disease within 5 years before radiotherapy (except tumours that likely do not impact prognosis and likely not require treatment interfering with study therapy, e.g. in-situ carcinoma of the breast or cervix uteri)
* pregnant or lactating women
* patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators
* patients not able to understand character and individual consequences of the clinical trial
* claustrophobic patients
* current participation in another clinical intervention study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No