Clinical trial · Interventional
Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
NCT02978677CI-TRIAL-00060036PANAMAnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy 60 Gy(RBE) | Radiation | — | UNRESOLVED |
| Radiotherapy 68 Gy(RBE) | Radiation | — | UNRESOLVED |
| Radiotherapy 72 Gy(RBE) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Grade II tumors (macroscopic)
- description
- Radiotherapy 68 Gy(RBE)
- interventionNames
- Radiation: Radiotherapy 68 Gy(RBE)
- type
- EXPERIMENTAL
- label
- Grade III tumors (macroscopic)
- description
- Radiotherapy 72 Gy(RBE)
- interventionNames
- Radiation: Radiotherapy 72 Gy(RBE)
- type
- ACTIVE_COMPARATOR
- label
- Grade II/III tumors (completely resected)
- description
- Radiotherapy 60 Gy(RBE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.