Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diag… (NCT00104936) | Clinical Trial Compass
TerminatedPhase 3
Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Chemo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival
Trial details
NCT IDNCT00104936
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC