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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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

adjuvant therapy

radiation therapy

stereotactic radiosurgery

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

NCT ID

NCT00104936

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

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

Brain and Central Nervous System Tumors

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial