Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study |
- Progression-free survival [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Mini-mental status exam [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 77 |
| Study Start Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Switzerland | |
| Hopital Cantonal Universitaire de Geneve | Recruiting |
| Geneva, Switzerland, CH-1211 | |
| Contact: Contact Person 41-22-372-3270 nci.pdq@eortc.be | |
| Study Chair: | Damien C. Weber, MD, PhD | Hopital Cantonal Universitaire de Geneve |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00626730 History of Changes |
| Other Study ID Numbers: | CDR0000583070, EORTC-22042, EORTC-26042, EudraCT-2005-005551-18 |
| Study First Received: | February 28, 2008 |
| Last Updated: | February 6, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult grade II meningioma adult grade III meningioma |
Additional relevant MeSH terms:
|
Meningioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue |
Meningeal Neoplasms Neoplasms by Site Nervous System Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013