AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 3NCT00104936

Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery

A Phase 3 study testing adjuvant therapy, radiation therapy and stereotactic radiosurgery in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
adjuvant therapy, radiation therapy and stereotactic radiosurgery
Type of treatment
Surgery or procedure
How many people
9 participants
Where
4 sitesin 3 countries
Study dates
Dec 2004to Nov 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Netherlands2 sites

  • Radiotherapeutisch Instituut-(Riso)

    Deventer, 7400 AC

  • University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, 3000 CA

Other trials in Netherlands

Germany1 site

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

Other trials in Germany

Switzerland1 site

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

Other trials in Switzerland

About this study

Official title: Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study

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.

Read the detailed description

OBJECTIVES:

Primary

  • Compare progression-free survival of patients with newly diagnosed, incompletely resected, benign intracranial grade I meningioma treated with adjuvant conventional fractionated radiotherapy or radiosurgery vs observation only.

Secondary

  • Compare the quality of life of patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.
  • Compare the incidence of a second surgery in patients treated with these regimens.
  • Compare the incidence of acute and long-term neurotoxicity in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to post-surgery MRI staging (3 vs 4 vs 5), skull base location (yes vs no), age (< 60 vs ≥ 60), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo observation only.
  • Arm II: Within 4-7 months after surgery, patients undergo conventional fractionated radiotherapy once daily, 5 days a week for 6 weeks OR a single treatment of high-dose radiosurgery in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, at 6 months after randomization, and then annually thereafter.

After completion of study treatment, patients are followed at 3 and 6 months after randomization and then annually thereafter.

PROJECTED ACCRUAL: A total of 478 patients (239 per treatment arm) will be accrued for this study within 3-4 years.

Being tested
adjuvant therapy, radiation therapy, stereotactic radiosurgery
Keywords
adult grade I meningioma
Medical subject headings
Central Nervous System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adjuvant therapyProcedure or surgery

  • radiation therapyRadiation

  • stereotactic radiosurgeryRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

Secondary outcomes (5)

  1. Quality of life

  2. Overall survival

  3. Incidence of a second surgery

  4. Acute neurotoxicity

  5. Long-term neurotoxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionNov 2006

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104936
Sponsor's protocol ID
EORTC-26021 -22021
Other IDs
EORTC-26021, EORTC-22021, CAN-NCIC-EORTC-26021
Status last verified
Sep 2012
First submitted
3 Mar 2005
Last updated
24 Sep 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adjuvant therapy, radiation therapy and stereotactic radiosurgery in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00104936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in