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Clinical Trials (PDQ®)

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentClosed3 to 21 at diagnosisNCI, OtherACNS0331
COG-ACNS0331, CDR0000365506, NCT00085735

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma.

PURPOSE: This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.

Further Study Information

OBJECTIVES:

Primary

  • Compare event-free and overall survival of pediatric patients (3 to 7 years of age) with newly diagnosed standard-risk medulloblastoma treated with standard-dose vs reduced-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with chemotherapy comprising vincristine, cisplatin, lomustine, and cyclophosphamide.
  • Compare event-free and overall survival of these patients (8 to 21 years of age) treated with standard-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with this chemotherapy regimen.

Secondary

  • Compare patterns of failure in patients treated with these regimens.
  • Compare the cognitive, auditory, and endocrinologic effects of these regimens in these patients.
  • Compare the audiologic and endocrinologic toxicity from these regimens in these patients.
  • Develop an optimal gene expression medulloblastoma outcome predictor.
  • Assess quality of life and functional status in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients will undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). Patients receive vincristine IV on days 8, 15, 22, 29, 36, and 43 (weeks 1-6) beginning 31 days after surgery.Patients 3 to 7 years of age are randomized to 1 of 2 chemoradiotherapy arms. Patients 8-21 years old are assigned to arm II.

  • Chemoradiotherapy:Patients will undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). Patients receive vincristine IV on days 8, 15, 22, 29, 36, and 43 (weeks 1-6) beginning 31 days after surgery. Patients 3 to 7 years of age are randomized to 1 of 2 radiotherapy arms (arms I and II). Patients 8-21 years old are assigned to arm II.
  • Radiotherapy (first randomization):
  • Arm I: Patients undergo reduced-dose craniospinal radiotherapy with boost.
  • Arm II: Patients undergo standard-dose craniospinal radiotherapy with boost. All patients are then randomized to 1 of 2 chemoradiotherapy arms (arms III and IV).
  • Radiotherapy boost (second randomization):
  • Arm III: Patients will undergo radiotherapy boost to the entire posterior fossa.
  • Arm IV: Patients will undergo radiotherapy boost to the tumor bed only.
  • Maintenance chemotherapy: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration.
  • Regimen A (courses 1, 2, 4, 5, 7, and 8): Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
  • Regimen B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed medulloblastoma located in the posterior fossa
  • Standard-risk disease
  • Minimal volume, non-disseminated disease, defined by the following:
  • Residual tumor ≤ 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days after surgery
  • No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following:
  • Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery
  • Negative cytological examination of CSF after surgery, but before study enrollment
  • Brain stem involvement allowed

PATIENT CHARACTERISTICS:

Age

  • 3 to 21 at diagnosis

Performance status

  • Karnofsky 50-100% (> 16 years of age) OR
  • Lansky 30-100% (≤ 16 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3 (transfusion independent)
  • Hemoglobin > 10 g/dL (transfusions allowed)

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST or ALT < 1.5 times ULN

Renal

  • Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior corticosteroids allowed

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Jeff M. MichalskiStudy Chair

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Alyssa T Reddy Ph: 205-934-0309
California
  Sacramento
 Sutter Cancer Center
 Jeff M. Michalski
  Santa Barbara
 Santa Barbara Cottage Hospital
 Daniel J Greenfield Ph: 805-682-7300
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Aziza T Shad Ph: 202-444-0381
Florida
  West Palm Beach
 Kaplan Cancer Center at St. Mary's Medical Center
 Narayana Gowda Ph: 888-823-5923
  Email: ctsucontact@westat.com
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Jeff M. Michalski
Michigan
  Detroit
 Wayne State University
 Jeff M. Michalski
  Kalamazoo
 Western Michigan University School of Medicine Clinics
 Jeffrey S Lobel Ph: 800-227-2345
Minnesota
  Saint Paul
 Children's Hospitals and Clinics of Minnesota - St. Paul
 Jeff M. Michalski
New Jersey
  Summit
 Overlook Hospital
 Steven L Halpern Ph: 973-971-5900
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Jeff M. Michalski
North Carolina
  Durham
 Duke Cancer Institute
 Susan G Kreissman Ph: 888-275-3853
  Greenville
 Leo W. Jenkins Cancer Center at ECU Medical School
 Mauro Grossi Ph: 252-744-2161
Oregon
  Portland
 Legacy Emanuel Hospital and Health Center and Children's Hospital
 Janice F Olson Ph: 503-413-2560
South Carolina
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Cary E Stroud Ph: 864-241-6251
Canada
Ontario
  Hamilton
 McMaster Children's Hospital at Hamilton Health Sciences
 Carol Portwine Ph: 905-521-2100ext74595

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00085735
ClinicalTrials.gov processed this data on September 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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