Clinical trial · Interventional
Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery
Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not yet known whether radiation therapy or radiosurgery is more effective than observation alone in treating benign meningioma. PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see how well they work compared to observation alone in treating patients with newly diagnosed, benign meningioma that has been partially removed by surgery.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
Secondary outcomes (5)
- measure
- Quality of life
- measure
- Overall survival
- measure
- Incidence of a second surgery
- measure
- Acute neurotoxicity
- measure
- Long-term neurotoxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed benign intracranial meningioma * WHO grade I * Any location except orbital meningioma * Mitotic index \< 4 (total counts per 10 high-power field) AND MIB-1 labeling index \< 4% * The following histologies are not allowed (i.e., WHO grade II or III): * Atypical * Clear cell * Choroid * Rhabdoid * Papillary * Anaplastic * Must have undergone non-radical resection\* within the past 7 months * Post-operative MRI (performed 4 months after surgery) demonstrating stages 3, 4, or 5 NOTE: \*Biopsy only is considered non-radical resection and may be classified as stage 4 or 5 according to tumor volume * No brain invasion * No hemangiopericytoma * No fibrous dysplasia or intra-osseous meningioma * No multiple meningiomas or meningiomatosis * Not part of neurofibromatosis type II PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No serious congestive heart failure Other * HIV negative * No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No other disease that would preclude 5-year follow up after study completion * No psychological, familial, sociological, or geographical condition that would preclude study compliance or study follow up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the meninges or brain that would preclude study treatment Surgery * See Disease Characteristics Other * No prior randomization to this study
References
Publications (0)
Data not yet available