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Not yet recruiting NCT02978677

Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas

No phase Interventional Meningioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy 68 Gy(RBE), Radiotherapy 72 Gy(RBE), Radiotherapy 60 Gy(RBE).
Who it may be relevant to
Registry conditions: Meningioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

  • Radiation Radiotherapy 68 Gy(RBE)
    Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton
  • 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
  • Radiation Radiotherapy 60 Gy(RBE)
    Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton

Primary outcome measures

  • progression-free survival [Time frame: 5 years after start of radiotherapy]
Secondary outcome measures (5)
  • late toxicity [Time frame: 5 years after start of radiotherapy]
  • acute toxicity [Time frame: 5 years after start of radiotherapy]
  • overall survival [Time frame: 5 years after start of radiotherapy]
  • patterns of recurrence using MRI [Time frame: 5 years after start of radiotherapy]
  • quality of life by validated quality of life questionnaires [Time frame: 5 years after start of radiotherapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT02978677 · STR-PANAMA-2015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗