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



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 21
Updated:3/21/2019
Start Date:April 2004
End Date:March 2016

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

This randomized phase III trial is studying how well standard-dose radiation therapy works
compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard
volume boost radiation therapy works compared to smaller volume boost radiation therapy when
given together with chemotherapy in treating young patients who have undergone surgery for
newly diagnosed standard-risk medulloblastoma. 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 is more
effective than reduced-dose radiation therapy when given together with chemotherapy after
surgery in treating young patients with medulloblastoma.

PRIMARY OBJECTIVES:

I. Compare event-free survival (EFS) of pediatric patients (3 to 7 years of age) with newly
diagnosed standard-risk medulloblastoma treated with standard-dose versus (vs.) reduced-dose
craniospinal radiotherapy (SDCSI vs. LDCSI).

II. Compare EFS of patients (3-21 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 OBJECTIVES:

I. Compare overall survival (OS) of pediatric patients (3-7 years of age) with newly
diagnosed standard-risk medulloblastoma treated with SDCSI vs. LDCSI.

II. Compare OS of patients (3-21 years of age) with newly diagnosed standard-risk
medulloblastoma treated with PFRT vs. IFRT.

III. To evaluate patterns of failure in patients treated with an irradiation boost volume
smaller than conventional posterior fossa volumes.

IV. To reduce the cognitive, auditory, and endocrinologic effects of treatment of
average-risk medulloblastoma by reducing the dose of craniospinal irradiation therapy.

V. To determine if the audiologic and endocrinologic toxicity will be reduced with the use of
limited tumor boost volume irradiation compared to patients treated with conventional target
volumes of radiation.

VI. Develop an optimal gene expression medulloblastoma outcome predictor, validated
prospectively in a multi-institution randomized clinical trial.

VII. To improve compliance with long-term quality of life (QoL) and functional status data
submission by educating institutional nurses to administer and submit for analysis a battery
of four instruments (Behavior Assessment System for Children- 2nd Edition (BASC-2), Adaptive
Behavior Assessment System - 2nd Edition (ABAS-II), Behavior Rating Inventory of Executive
Function (BRIEF) and PedsQLTM 4.0).

OUTLINE: Patients 3-7 years of age are randomized to 1 of 4 arms (Arm I-IV). Patients 8-21
years of age are randomized to 1 of 2 arms (Arm V or VI).

Within 31 days after definitive surgery, all patients begin therapy. Patients undergo
radiation therapy with doses according to their Arm randomization on days 1-5, 8-12, 15-19,
22-26, 29-33, 36-40, and 43-47 (weeks 0-6). All patients receive vincristine intravenously
(IV) over 1 minute (or infusion via minibag as per institutional policy) on days 8, 15, 22,
29, 36, and 43 (weeks 1-6).

ARM I: Patients 3-7 years of age undergo lowered dose craniospinal irradiation (LDCSI) with
involved-field radiation therapy (IFRT) boost.

ARM II: Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy
(PFRT) boost.

ARM III: Patients 3-7 years of age undergo standard dose craniospinal irradiation (SDCSI)
with IFRT boost.

ARM IV: Patients 3-7 years of age undergo SDCSI with PFRT boost.

ARM V: Patients 8-21 years of age undergo SDCSI with IFRT boost.

ARM VI: Patients 8-21 years of age undergo SDCSI with PFRT boost.

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 lomustine orally 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.

Inclusion Criteria:

- 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

- Performance status - Karnofsky 50-100% (> 16 years of age)

- Performance status - Lansky 30-100% (≤ 16 years of age)

- Absolute neutrophil count > 1,500/uL

- Platelet count > 100,000/uL (transfusion independent)

- Hemoglobin > 10 g/dL (transfusions allowed)

- Bilirubin < 1.5 times upper limit of normal (ULN) for age

- AST or ALT < 1.5 times ULN for age

- Creatinine clearance OR radioisotope glomerular filtration rate >= 70 mL/min/1.73m^2
or a serum creatinine based on age/gender as follows:

Age Maximum Serum Creatine (mg/dL)

- 1month to < 6 months male: 0.4 female: 0.4

- 6 months to <1 year male: 0.5 female: 0.5

- 1 year to < 2 years male: 0.6 female: 0.6

- 2 to < 6 years male: 0.8 female: 0.8

- 6 to < 10 years male: 1 female: 1

- 10 to < 13 years male: 1.2 female: 1.2

- 13 to < 16 years male: 1.5 female: 1.4

- >= 16 years male: 1.7 female: 1.4

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior chemotherapy

- Prior corticosteroids allowed

- No prior radiotherapy
We found this trial at
157
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1201 Camino de Salud Northeast
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4900 Mueller Boulevard
Austin, Texas 78723
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
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1600 7th Avenue
Birmingham, Alabama 35233
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Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
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Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1 Hurley Plaza
Flint, Michigan 48503
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
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100 Michigan Street Northeast
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2500 N State St
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San Antonio, Texas 78229
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3020 Childrens way
San Diego, California 92123
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Valhalla, New York 10595
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1600 Rockland Road
Wilmington, Delaware 19803
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
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Chapel Hill, North Carolina 27599
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Charleston, South Carolina 29425
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Knoxville, Tennessee 37916
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