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Brain and Central Nervous System TumorsPhase 2NCT00895622

Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

A Phase 2 study testing 54 Gy radiotherapy and 60 Gy radiotherapy in people with Brain and Central Nervous System Tumors, run by Radiation Therapy Oncology Group at 78 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
54 Gy radiotherapy and 60 Gy radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
78 sitesin 2 countries
Study dates
Jun 2009to 15 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A histologically documented World Health Organization (WHO) grade I, II, or III meningioma, newly diagnosed or recurrent, and of any resection extent, confirmed by central pathology review. Patients are partitioned according to three groupings: Group I (low risk), Group II (intermediate risk), and Group III (high risk) as defined below:
  • Group I (low risk): Patients with a newly diagnosed WHO grade I meningioma that has been gross totally resected (Simpson's grade I, II, or III resections, with no residual nodular enhancement on postoperative imaging) or subtotally resected (residual nodular enhancement or Simpson grade IV or V excision). The extent of resection will be based upon the neurosurgeons' assessment and postoperative MR imaging.
  • Group II (intermediate risk): Patients with a newly diagnosed gross totally resected WHO grade II meningioma or patients with a recurrent WHO grade I meningioma irrespective of the resection extent. Resection extent will be recorded on the same basis described above for the low-risk group.
  • Group III (high risk): Patients with a newly diagnosed or a recurrent WHO grade III meningioma of any resection extent; patients with a recurrent WHO grade II meningioma of any resection extent; or patients with a newly diagnosed subtotally resected WHO grade II meningioma. In the setting of a newly diagnosed meningioma, the histologic diagnosis must have been reached within 6 months of Step 2 registration. Resection extent will be recorded on the same basis described above for the low-risk group.
  • 1.1 In the setting of a newly diagnosed meningioma, the histologic diagnosis must have been reached within 24 weeks prior to Step 2 registration. In the setting of a recurrent meningioma, there are no such time constraints. Additional resection or biopsy is encouraged for patients with recurrence but is not requisite. If further biopsy or resection is performed at recurrence, these specimens must be submitted; submission of the original pathology specimens is encouraged but not required. The diagnosis of recurrence solely on the basis of imaging findings is permitted, but if no additional resection is performed, specimens from prior resection must be submitted.
  • 1.2 In cases of newly diagnosed or surgically treated recurrent meningioma, the operating neurosurgeon must provide a Simpson grade for the degree of resection.
Show all 17Show fewer
  • History/physical examination, including neurologic examination, within 8 weeks prior to Step 2 registration
  • Zubrod Performance Status 0-1
  • Age ≥ 18
  • All patients must have a magnetic resonance imaging (MRI) scan within 12 weeks prior to Step 2 registration. Both preoperative and postoperative MRIs are required for all newly diagnosed patients in groups I, II, or III. In the setting of group II or III patients with recurrent/progressive meningioma and without recent surgery, a pre-operative study may not apply, although MRI documentation of recurrence or progression is required. MRIs must include precontrast T1, T2, and flair images and multiplanar (axial, sagittal, and coronal) postcontrast T1. The postoperative study must be completed within 12 weeks of surgery.
  • 5.1 Group I: All group I patients will have surgery. Preoperative and postoperative MRIs are thus required in order to assess resection extent.
  • 5.2 Group II: Surgery will be undertaken for the subgroup with a gross totally resected WHO grade II meningioma. For these patients preoperative and postoperative MRIs are necessitated. For the other subgroup with recurrent WHO grade I meningioma, preoperative and postoperative MRIs are required if surgery is undertaken for the recurrent/progressive tumor. However, only the follow-up imaging documenting recurrence or progression will apply if further surgery is not completed.
  • 5.3 Group III: Surgery will be undertaken for the subgroup with a newly diagnosed WHO grade III meningioma. For these patients preoperative and postoperative MRIs are obligatory. For the subgroups with recurrent WHO grade II or III meningioma, preoperative and postoperative MRIs are required if surgery is undertaken for the recurrent/progressive tumor. However, only the follow-up imaging documenting recurrence or progression will apply if further surgery is not completed.
  • For woman of childbearing potential who are intermediate or high risk:
  • 6.1 Negative serum pregnancy test within 14 days prior to Step 2 registration
  • 6.2 The patient must agree to practice adequate contraception from the time of the negative serum pregnancy test throughout the entire course of EBRT.
  • Patient must sign study-specific informed consent prior to study entry

Who cannot join

  • Extracranial meningioma
  • Multiple meningiomas
  • Hemangiopericytoma
  • Major medical illnesses or psychiatric impairments which, in the investigators opinion, will prevent administration or completion of the protocol therapy or preclude informed consent
  • Previous radiation therapy to the scalp, cranium, brain, or skull base
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
Show all 15Show fewer
  • Patients with severe, active comorbidity including, but not restricted to:
  • 7.1 Unstable angina and/or congestive heart failure requiring hospitalization at the time of Step 2 registration
  • 7.2 Transmural myocardial infarction within the last 6 months
  • 7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of Step 2 registration
  • 7.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of Step 2 registration
  • 7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  • 7.6 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • 7.7 Active connective tissue disorders such as lupus or scleroderma if the patient is intermediate or high risk
  • Inability to receive gadolinium

Trial locations and contacts

78 sites in 2 countries.

78 sites in 2 countries

United States74 sites

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Emory Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Norton Suburban Hospital

    Louisville, Kentucky, 40207

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Community Memorial Hospital Cancer Care Center

    Menomonee Falls, Wisconsin, 53051

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • CCOP - Kansas City

    Prairie Village, Kansas, 66208

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Norris Cotton Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care

    Springfield, Massachusetts, 01107

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Door County Cancer Center at Door County Memorial Hospital

    Sturgeon Bay, Wisconsin, 54235-1495

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

Other trials in United States

Canada4 sites

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1Y 4E9

Other trials in Canada

About this study

Official title: Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

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.

Read the 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.

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

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

Being tested
54 Gy radiotherapy, 60 Gy radiotherapy
Keywords
adult grade I meningioma, adult grade II meningioma, adult grade III meningioma, adult anaplastic meningioma, adult papillary meningioma, recurrent adult brain tumor
Medical subject headings
Central Nervous System Neoplasms, Meningioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 54 Gy radiotherapyRadiation

    Also called external beam radiation therapy (EBRT), radiation therapy (RT), Proton therapy, Three-dimensional conformal radiotherapy (3D-CRT)

    External beam radiation therapy (EBRT) to a total dose of 54 Gy (RBE) in 30 fractions. 1.8 Gy (RBE) daily, 5 fractions per week, excluding weekends. 3D-CRT or IMRT or Proton allowed.

  • 60 Gy radiotherapyRadiation

    Also called external beam radiation therapy (EBRT), radiation therapy, Intensity-modulated radiation therapy (IMRT)

    External beam radiation therapy using intensity-modulated radiation therapy (IMRT) to a total dose of 60 Gy in 30 fractions. 2.0 Gy daily, 5 fractions per week, excluding weekends.

Study groups in NCT00895622
Study groupRoleWhat they receive
Low RiskNo interventionNo treatment given.
Intermediate RiskExperimental54 Gy radiotherapy
Receives: Radiation: 54 Gy radiotherapy
High RiskExperimental60 Gy radiotherapy
Receives: Radiation: 60 Gy radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival Rate at 3 Years

    Progression was determined by central review of magnetic resonance imaging (MRI) exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival (PFS) rates are estimated using the binomial method.

    Measured: From registration to 3 years

Secondary outcomes (10)

  1. Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]

    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. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Measured: From start of radiation to 90 days.

  2. Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]

    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. Late adverse events are those occurring more than 90 days from start of radiation therapy.

    Measured: Ninety-one days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 6.3 years.

  3. Overall Survival Rate at 3 Years

    Overall survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

    Measured: From registration to 3 years

  4. Progression-free Survival Rate at 3 Years (Kaplan-Meier Method)

    Progression was determined by central review of MRI exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.

    Measured: From registration to 3 years

  5. Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years

    MRI's were centrally reviewed by the study neuroradiology co-chairs for presence of edema, homogeneous enhancement, calcification, hyperostosis, and brain invasion. Data is presented for all risk groups combined, with time points presented in each column. Neither risk groups nor time points are compared.

    Measured: Baseline, at time of first progression, and at 3 years

  6. Greatest Single Dimension From MRI as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years

    MRI's were centrally reviewed by the study neuroradiology co-chairs. Data is presented for all risk groups combined, with time points presented in each column. Neither risk groups nor time points are compared.

    Measured: Baseline, at time of first progression, and at 3 years

  7. Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters

    The principle investigator performed a radiotherapy quality assurance (QA) review.

    Measured: After treatment delivery

  8. Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping

    A pathology review was conducted both by the institution and centrally, with three possible choices for grade / subtype: World Health Organization (WHO) Grade I / benign; WHO grade II / atypical; WHO grade III / anaplastic. Data is presented for all risk groups combined.

    Measured: Baseline

  9. Molecular Correlative Studies

    Measured: From registration to 3 years

  10. Histopathologic Correlates of PFS Including Light Microscopy, Immunohistochemical Analysis, and Microarray Analysis

    Measured: From registration to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2016
  4. Study completion15 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00895622
Sponsor's protocol ID
RTOG-0539
Other IDs
CDR0000641815
Status last verified
Aug 2023
First submitted
7 May 2009
Last updated
8 Sep 2023
Data monitoring committee
Yes

Publications

  • Rogers CL, Perry A, Pugh S, Vogelbaum MA, Brachman D, McMillan W, Jenrette J, Barani I, Shrieve D, Sloan A, Bovi J, Kwok Y, Burri SH, Chao ST, Spalding AC, Anscher MS, Bloom B, Mehta M. Pathology concordance levels for meningioma classification and grading in NRG Oncology RTOG Trial 0539. Neuro Oncol. 2016 Apr;18(4):565-74. doi: 10.1093/neuonc/nov247. Epub 2015 Oct 22.

    PubMed 26493095

  • Yefet LS, Landry AP, Rogers CL, Wang JZ, Liu J, Patil V, Gui C, Ajisebutu A, Ellenbogen Y, Wei Q, Singh O, Mansouri S, Szot C, Jordan RC, Barani IJ, Straza MW, Shu HG, Pointer KB, Hunter G, Panet-Raymond V, Shi W, Perlow HK, Kavanagh BD, Gunter T, Robinson C, Pugh SL, Dicker AP, Mehta MP, Chakravarti A, Nassiri F, Aldape K, Zadeh G. Modern molecular profiling recontextualizes the NRG/RTOG 0539 trial and reveals hidden high-risk and radiotherapy-resistant meningiomas. Neuro Oncol. 2026 Jul 1;28(7):1727-1740. doi: 10.1093/neuonc/noag081.

    PubMed 42143623

  • Rogers CL, Won M, Vogelbaum MA, Perry A, Ashby LS, Modi JM, Alleman AM, Galvin J, Fogh SE, Youssef E, Deb N, Kwok Y, Robinson CG, Shu HK, Fisher BJ, Panet-Raymond V, McMillan WG, de Groot JF, Zhang P, Mehta MP. High-risk Meningioma: Initial Outcomes From NRG Oncology/RTOG 0539. Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):790-799. doi: 10.1016/j.ijrobp.2019.11.028. Epub 2019 Nov 29.

    PubMed 31786276

  • Rogers L, Zhang P, Vogelbaum MA, Perry A, Ashby LS, Modi JM, Alleman AM, Galvin J, Brachman D, Jenrette JM, De Groot J, Bovi JA, Werner-Wasik M, Knisely JPS, Mehta MP. Intermediate-risk meningioma: initial outcomes from NRG Oncology RTOG 0539. J Neurosurg. 2018 Jul;129(1):35-47. doi: 10.3171/2016.11.JNS161170. Epub 2017 Oct 6.

    PubMed 28984517

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 54 Gy radiotherapy and 60 Gy radiotherapy in people with Brain and Central Nervous System Tumors, run by Radiation Therapy Oncology Group at 78 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival Rate at 3 Years (time frame: From registration to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00895622, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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