Trial record 1 of 1 for:    RTOG 0539
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Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00895622
First received: May 7, 2009
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether observation is more effective than radiation therapy in treating patients with meningioma.

PURPOSE: This phase II trial is studying observation to see how well it works compared with radiation therapy in treating patients with grade I, grade II, or grade III meningioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Other: clinical observation
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy (IMRT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Progression-free survival rate at 3 years [ Time Frame: From registration to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: From start of radiation to 90 days ] [ Designated as safety issue: Yes ]
    Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown.

  • Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for late adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: From 91 days after start of radiation to death or 10 years, whichever is first ] [ Designated as safety issue: Yes ]
    Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for late adverse events as assessed by NCI CTCAE v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown.

  • Survival rate at 3 years [ Time Frame: From registration to 3 years ] [ Designated as safety issue: No ]
  • MRI imaging predictors as assessed by central neuroradiology review at diagnosis, at any failure, and at 3 years [ Time Frame: From registration to 3 years ] [ Designated as safety issue: No ]
  • Adherence to protocol-specific target and normal tissue radiotherapy parameters [ Time Frame: After treatment delivery ] [ Designated as safety issue: No ]
  • Concordance between central and parent institution histopathologic grading and subtyping [ Time Frame: From 4 weeks of block receipt for central review of eligibility. ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: June 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Patients undergo clinical observation.
Other: clinical observation
Patients undergo observation.
Experimental: Group 2
Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks.
Radiation: 3-dimensional conformal radiation therapy
Patients undergo 3-dimensional conformal radiation therapy once daily 5 days a week for 6 weeks
Radiation: intensity-modulated radiation therapy (IMRT)
Patients undergo IMRT once daily 5 days a week for 6 weeks
Experimental: Group 3
Patients undergo IMRT once daily 5 days a week for 6 weeks.
Radiation: intensity-modulated radiation therapy (IMRT)
Patients undergo IMRT once daily 5 days a week for 6 weeks

Detailed Description:

OBJECTIVES:

Primary

  • To estimate the rates of progression-free survival at 3 years in patients with low-risk meningioma undergoing observation and in patients with intermediate- or high-risk meningioma undergoing radiotherapy.

Secondary

  • To study the concordance, or lack thereof, between central and parent institution histopathologic diagnosis, grading, and subtyping.
  • To estimate the rates of overall survival at 3 years in these patients.
  • To estimate the incidence rates of acute and late adverse events ≥ grade 2 in patients with intermediate- or high-risk meningioma undergoing radiotherapy.
  • To evaluate MRI imaging predictors by central neuroradiology review at diagnosis, at any failure, and at 3 years.
  • To evaluate adherence to protocol-specific target and normal tissue radiotherapy parameters.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 groups according to risk.

  • Group 1 (low-risk disease): Patients undergo observation.
  • Group 2 (intermediate-risk disease): Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks.
  • Group 3 (high-risk disease): Patients undergo IMRT once daily 5 days a week for 6 weeks.

After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually for 10 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed meningioma, meeting 1 of the following criteria:

    • Low-risk disease, as defined by the following:

      • Newly diagnosed, WHO grade I disease that was gross totally resected (Simpson's grade I, II, or III resection with no residual nodular enhancement on postoperative imaging) or subtotally resected (residual nodular enhancement or Simpson grade IV or V resection)
    • Intermediate-risk disease, as defined by the following:

      • Newly diagnosed, WHO grade II disease that was gross totally resected OR recurrent WHO grade I disease irrespective of the resection extent
    • High-risk disease, as defined by 1 of the following:

      • Newly diagnosed or recurrent WHO grade III disease of any resection extent
      • Recurrent WHO grade II disease of any resection extent
      • Newly diagnosed, WHO grade II disease that was subtotally resected
  • Patients with newly diagnosed disease must have had a histologic diagnosis within the past 6 months AND have undergone pre- and post-operative MRIs within the past 3 months
  • Patients with recurrent/progressive intermediate- or high-risk disease who have not undergone recent surgery must have documentation of recurrence or progression by MRI within the past 3 months
  • No extracranial or multiple meningioma and/or hemangiopericytoma

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Negative pregnancy test (for patients enrolled in groups 2 or 3)
  • Fertile patients must use effective contraception (for patients enrolled in groups 2 or 3)
  • Able to receive gadolinium
  • No other invasive malignancy within the past 3 years except for nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active comorbidity including, but not limited to, any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial and/or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or respiratory illness requiring hospitalization or that would preclude study treatment
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • Known HIV positivity or AIDS, based upon the current Centers for Disease Control (CDC) definition
    • No evidence of active connective tissue disorders (e.g., lupus erythematosus and/or scleroderma) (for patients enrolled in groups 2 or 3)
  • No other major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study treatment or informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to the scalp, cranium, brain, or skull base
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895622

  Show 78 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: C. Leland Rogers, MD Salt Lake Regional Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00895622     History of Changes
Other Study ID Numbers: RTOG-0539, CDR0000641815
Study First Received: May 7, 2009
Last Updated: October 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
adult anaplastic meningioma
adult papillary meningioma
recurrent adult brain tumor

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

ClinicalTrials.gov processed this record on April 14, 2014