Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma

NCT00626730 | Unknown Phase 2

• 4 other identifiers: EORTC-22042-26042EORTC-22042EORTC-260422005-005551-18
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult grade II meningioma; adult grade III meningioma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (3)

• Adverse events as assessed by NCI CTCAE v3.0

• Mini-mental status exam

• Overall survival

Interventions

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Meningioma

Interventions

Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Damien C. Weber, MD, PhD

  Hopital Cantonal Universitaire de Geneve

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: February 29, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2013
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

CH (1)