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A PHASE III PROSPECTIVE RANDOMIZED STUDY OF CRANIOSPINAL RADIOTHERAPY FOLLOWED BY ONE OF TWO ADJUVANT CHEMOTHERAPY REGIMENS (CCNU, CDDP, VCR OR CPM, CDDP, VCR) IN CHILDREN WITH NEWLY-DIAGNOSED AVERAGE-RISK MEDULLOBLASTOMA


Phase 3
3 Years
22 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A PHASE III PROSPECTIVE RANDOMIZED STUDY OF CRANIOSPINAL RADIOTHERAPY FOLLOWED BY ONE OF TWO ADJUVANT CHEMOTHERAPY REGIMENS (CCNU, CDDP, VCR OR CPM, CDDP, VCR) IN CHILDREN WITH NEWLY-DIAGNOSED AVERAGE-RISK MEDULLOBLASTOMA


OBJECTIVES: I. Assess whether a cyclophosphamide-containing combination chemotherapy regimen
increases progression-free survival compared to a lomustine-containing regimen in children
with newly diagnosed, average-risk medulloblastoma. II. Determine progression-free and
overall survival of children treated with craniospinal radiotherapy and local boost
radiotherapy for a total dose of 5580 cGy followed by adjuvant
lomustine/cisplatin/vincristine vs. cyclophosphamide/cisplatin/vincristine. III. Determine
the long-term neurocognitive, endocrinologic, and cardiopulmonary sequelae associated with
craniospinal radiotherapy, local boost radiotherapy, and adjuvant chemotherapy in these
children, and determine whether replacement of lomustine with cyclophosphamide alters the
incidence and degree of sequelae. IV. Determine whether cellular and biologic parameters,
including tumor molecular genetic analysis, DNA ploidy, mitotic activity markers, and
immunohistochemical analysis, are correlated with progression-free survival, overall
survival, and patterns of disease relapse in these patients. V. Evaluate the utility of
routine magnetic resonance imaging surveillance studies of the head and spine in detecting
subclinical recurrent disease.

OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Following surgery, patients are randomized to one of two groups. The first group receives
craniospinal irradiation followed by a boost to the primary tumor. Beginning within 1 week
after initiation of radiotherapy, patients receive vincristine weekly for 8 doses. Beginning
6 weeks after the completion of radiotherapy, patients receive adjuvant
lomustine/vincristine/cisplatin every 6 weeks for a total of 8 courses. The second group
receives craniospinal irradiation plus vincristine as above, followed by adjuvant
cyclophosphamide/vincristine/cisplatin every 6 weeks for a total of 8 courses. Patients are
followed every 3 months for 1 year, every 6 months for 2 years, then annually.

PROJECTED ACCRUAL: It is anticipated that 240-300 patients will be entered over 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Pathologically confirmed posterior fossa medulloblastoma (CCG
diagnosis code 2041) Localized disease required, i.e.: No more than 1.5 square centimeters
of residual tumor on postoperative contrast-enhanced CT or MRI (preferably within 72 hours
but no more than 14 days after surgery) No evidence of metastatic disease on pre- and
postoperative MRI of spine (with dye enhancement) and lumbar cerebrospinal fluid (CSF)
cytology within 3 days prior to surgery Cytologic analysis of ventricular CSF allowed only
if medical contraindication to lumbar puncture and with approval of study chairperson
Brain stem involvement eligible

PATIENT CHARACTERISTICS: Age: 3 to 21 at diagnosis Performance status: Not specified
Hematopoietic: ANC greater than 1,500/mm3 Platelet count greater than 100,000/mm3
Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL ALT less than 1.5
times normal Renal: Nuclear glomerular filtration rate or creatinine clearance greater
than 70 mL/min per 1.73 square meters

PRIOR CONCURRENT THERAPY: No prior radiotherapy or chemotherapy (other than
corticosteroids) No more than 31 days since definitive surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Roger J. Packer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065160

NCT ID:

NCT00002875

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Via Christi Regional Medical CenterWichita, Kansas  67214
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794