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

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.

Official Title

A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial

Conditions

Brain and Central Nervous System Tumors

Study Type

Interventional

Study Design

Treatment, Randomized, Active Control

Further Details

Primary Outcome Measures:

• Time to event as measured by the time to disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm at 3 years

Secondary Outcome Measures:

• Time to recurrence, progression, or death due to cancer at 3 years
• Time to death at 3 years
• Local Posterior Fossa (LPF) Failure as determined by tumor recurrence or progression within the tumor bed at 3 years
• Non-local Posterior Fossa (NLPF) Failure as determined by recurrence outside CTVboost but within CTVPF at 3 years
• Non-Posterior Fossa (NPF) Failure as determine by recurrence within the neuroaxis but outside of CTVPF at 3 years
• Post-treatment neurocognitive function as measured by Neuropsychometric battery at 3 years
• Post-treatment hearing loss as measure by Audiogram or brainstem auditory evoked response (BAER) at 3 years
• Post-treatment endocrine function (e.g., growth, sexual maturation, and need for hormone replacement) by laboratory assesment, clinical history, and exam at 3 years
• Quality of Life as meastured by Pediatric Quality of Life Inventory (PedsQL), Behavior Assessment System for Children (BASC), Behavior Rating Inventory of Executive Function (BRIEF), and Adaptive Behavior Assessment System (ABAS) at 3 years

Study Start

April 2004

Eligibility & Criteria

• Ages Eligible for Study: 3 Years – 21 Years
• Genders Eligible for Study: Both

Inclusion 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 cm² 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:
    1. Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery
    2. 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 50-100% (< 16 years of age)
• Hematopoietic:
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³ (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
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy
• Prior corticosteroids allowed

Total Enrolment

600

Contact Details

Women’s and Children’s Hospital, North Adelaide, South Australia, 5006, Australia; Recruiting

• Maria L. Kirby: 61881617411

Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia; Recruiting

• David Baker: 011-6189340-8234

For more information on this trial, click here