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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00626730
First received: February 28, 2008
Last updated: February 6, 2009
Last verified: February 2008

February 28, 2008
February 6, 2009
December 2007
Not Provided
Progression-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626730 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
77
Not Provided
Not Provided

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
Both
18 Years to 70 Years
No
Not Provided
Switzerland
 
NCT00626730
CDR0000583070, EORTC-22042, EORTC-26042, EudraCT-2005-005551-18
Not Provided
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Damien C. Weber, MD, PhD Hopital Cantonal Universitaire de Geneve
National Cancer Institute (NCI)
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP