Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
Primary Purpose
Brain and Central Nervous System Tumors
Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
adjuvant therapy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult grade II meningioma, adult grade III meningioma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed meningioma, including the following subtypes:
Atypical WHO grade II meningioma greater than or equal to 4 mitosis per high-power field [HPF] or the presence of at least 3 of the following variables:
- Cellularity
- Architectural sheeting (i.e., patternless pattern)
- Macronuclei cell formation
- Small cell formation
- Malignant WHO grade III meningioma
- All locations allowed except for optic nerve sheets tumors
- Complete or subtotal resection as assessed by the surgeon after verification with a postoperative MRI and according to Simpson guidelines
- No neurofibromatosis type 2 (NF-2)
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Not pregnant or nursing
- Fertile patients must use effective contraception during study therapy
- May be registered on this trial only once
- No clinical evidence of second malignancies except carcinoma in situ of the cervix or basocellular carcinoma
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the brain or meninges interfering with the protocol treatment plan
Sites / Locations
- Hopital Cantonal Universitaire de Geneve
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Adverse events as assessed by NCI CTCAE v3.0
Mini-mental status exam
Overall survival
Full Information
NCT ID
NCT00626730
First Posted
February 28, 2008
Last Updated
February 2, 2021
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00626730
Brief Title
Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
Official Title
Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (Actual)
Primary Completion Date
February 2013 (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
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying radiation therapy to see how well it works in treating patients who have undergone surgery for newly diagnosed grade II or grade III meningioma.
Detailed Description
OBJECTIVES:
Primary
To assess the impact of high-dose radiotherapy (RT) on progression-free survival (PFS), treatment tolerance, and post-treatment global cognitive functioning in patients with atypical (WHO grade II) or malignant ( WHO grade III) meningioma.
OUTLINE: Patients with grade II disease are stratified according to resection status (complete excision [Simpson's stages 1-3] vs incomplete excision [Simpson's stages 4-5]) and participate in a phase II study. These patients are assigned to 1 of 2 treatment groups according to Simpson staging. Only data from these patients is analyzed with respect to the progression-free survival endpoint. Patients with grade III disease are treated in group 1 or 2 according to Simpson staging (as patients with grade II disease). After treatment, the clinical results from these patients are observed and described.
Group 1 (Simpson stage 1-3): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 6 weeks.
Group 2 (Simpson stage 4-5): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 7 weeks.
Patients complete a Mini-Mental Status Exam at baseline and at 6 weeks and 6 months after completion of study.
After completion of study treatment, patients are followed at 6 weeks, at 6 and 12 months, and then annually for at least 3 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 II meningioma, adult grade III meningioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Adverse events as assessed by NCI CTCAE v3.0
Title
Mini-mental status exam
Title
Overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed meningioma, including the following subtypes:
Atypical WHO grade II meningioma greater than or equal to 4 mitosis per high-power field [HPF] or the presence of at least 3 of the following variables:
Cellularity
Architectural sheeting (i.e., patternless pattern)
Macronuclei cell formation
Small cell formation
Malignant WHO grade III meningioma
All locations allowed except for optic nerve sheets tumors
Complete or subtotal resection as assessed by the surgeon after verification with a postoperative MRI and according to Simpson guidelines
No neurofibromatosis type 2 (NF-2)
PATIENT CHARACTERISTICS:
WHO performance status 0-2
Not pregnant or nursing
Fertile patients must use effective contraception during study therapy
May be registered on this trial only once
No clinical evidence of second malignancies except carcinoma in situ of the cervix or basocellular carcinoma
No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
No prior radiotherapy to the brain or meninges interfering with the protocol treatment plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien C. Weber, MD, PhD
Organizational Affiliation
Hopital Cantonal Universitaire de Geneve
Official's Role
Study Chair
Facility Information:
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
Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
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