Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

Official Title

Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

Summary:

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumour cells and shrink tumours.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS)

Secondary Outcome:

• Overall Survival (OS)
• 5 Year Overall Survival (OS)
• Disease-Specific Survival (DSS)
• 3 Year Disease-Specific Survival (DSS)
• 5 Year Disease-Specific Survival (DSS)
• 3 Year Progression-Free Survival (PFS)
• 5 Year Progression-Free Survival (PFS)
• Neurocognitive Function (NCF)
• Patient Reported Outcomes (PRO) as assessed by MDASI-BT
• Assessment of pHH3 mitotic index
• Incidence of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4 (exclusive of alopecia)

PRIMARY OBJECTIVES:

• To determine, in terms of progression-free survival (PFS), the extent of clinical benefit of the addition of adjuvant radiation therapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.
  

SECONDARY OBJECTIVES:

• Overall survival (OS).
  
• Disease-specific survival (DSS).
  
• Toxicity (grade 3+, exclusive of expected alopecia).
  
• Neurocognitive function (NCF).
  
• Outcomes and patient reported outcomes (PRO) measurements.
  
• Adherence to protocol-specific target and normal tissue parameters.
  
• Concordance measurements of central versus parent-institution pathology.
  
• Tissue microarray construction, and assessment of pHH3 mitotic index and molecular correlates to OS.

OUTLINE:

Patients are randomized to 1 of 2 arms after undergoing gross total resection. ARM I: Patients undergo observation. ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each). After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.

View this trial on ClinicalTrials.gov