Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas

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Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02978677
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Technische Universität Dresden
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mechthild Krause, Prof.
Principal Investigator Affiliation	Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Meningioma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Grade II tumors (macroscopic)

Radiotherapy 68 Gy(RBE)

Experimental: Grade III tumors (macroscopic)

Radiotherapy 72 Gy(RBE)

Active Comparator: Grade II/III tumors (completely resected)

Radiotherapy 60 Gy(RBE)

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Mechthild Krause, Prof.

[email protected]

+49 351 458 5441

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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