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:5/20/2016
Start Date:April 2004

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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 and overall survival 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) and posterior fossa boost vs tumor
bed boost radiotherapy (PFRT vs. IFRT) in combination with chemotherapy comprising
vincristine, cisplatin, lomustine, and cyclophosphamide.

II. 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 OBJECTIVES:

I. Compare patterns of failure in patients treated with PFRT vs. IFRT. II. Compare the
cognitive, auditory, and endocrinologic effects of these regimens in patients treated with
SDCSI vs. LDCSI.

III. Compare the audiologic and endocrinologic toxicity from these regimens in patients
treated with PFRT vs. IFRT.

IV. Develop an optimal gene expression medulloblastoma outcome predictor. V. Assess quality
of life and functional status in patients treated with these regimens.

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
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100 E Idaho St
Boise, Idaho 83712
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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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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1 South Prospect Street
Burlington, Vermont 05401
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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700 Childrens Drive
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
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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
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1200 Pleasant Street
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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
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1 Hurley Plaza
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3551 Roger Brooke Dr
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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3181 Southwest Sam Jackson Park Road
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Wilmington, Delaware 19803
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