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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
adjuvant therapy
radiation therapy
stereotactic radiosurgery
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult grade I meningioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Schleswig-Holstein - Kiel Campus
  • Radiotherapeutisch Instituut-(Riso)
  • University Medical Center Rotterdam at Erasmus Medical Center
  • Hopital Cantonal Universitaire de Geneve

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Quality of life
Overall survival
Incidence of a second surgery
Acute neurotoxicity
Long-term neurotoxicity

Full Information

First Posted
March 3, 2005
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00104936
Brief Title
Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery
Official Title
Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
December 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
NCIC Clinical Trials Group

4. Oversight

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult grade I meningioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Quality of life
Title
Overall survival
Title
Incidence of a second surgery
Title
Acute neurotoxicity
Title
Long-term neurotoxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John G. Wolbers, MD, PhD
Organizational Affiliation
University Medical Center Rotterdam at Erasmus Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raymond Miralbell, MD
Organizational Affiliation
Hopital Cantonal Universitaire de Geneve
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rolando F. Del Maestro, MD, PhD
Organizational Affiliation
Montreal Neurological Institute and Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luis Souhami, MD
Organizational Affiliation
McGill Cancer Centre at McGill University
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Schleswig-Holstein - Kiel Campus
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Radiotherapeutisch Instituut-(Riso)
City
Deventer
ZIP/Postal Code
7400 AC
Country
Netherlands
Facility Name
University Medical Center Rotterdam at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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