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Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00027846
Collaborator
National Cancer Institute (NCI) (NIH)
378
Enrollment
165
Locations
3
Arms
152
Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the local control and pattern of failure in children with completely resected, differentiated, supratentorial localized ependymoma after initial surgical resection alone.

  • Determine the rate of complete resection with second surgery after chemotherapy in patients with initially incompletely resected localized ependymoma.

  • Determine the local control and pattern of failure in patients treated with conformal radiotherapy.

  • Determine the influence of histologic grade on the time to progression in patients after treatment with conformal radiotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection.

  • Group 1 (patients with supratentorial differentiated ependymoma who have undergone gross total resection and have no visible residual tumor): Patients undergo observation.

  • Group 2 (patients with supratentorial anaplastic ependymoma or infratentorial anaplastic or differentiated ependymoma who have undergone gross total resection or near total resection): Patients undergo conformal radiotherapy to the brain once daily 5 days a week for 6-6½ weeks.

  • Group 3 (patients with tumor of any histology or location who have undergone subtotal resection): Patients receive an initial course of chemotherapy comprising vincristine IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second surgery. Patients who have unresectable disease undergo conformal radiotherapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.

Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 250-350 patients will be accrued for this study within 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
378 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma
Study Start Date :
Aug 1, 2003
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Mar 31, 2016

Arms and Interventions

Arm Intervention/Treatment
No Intervention: GTR1 Differentiated Histology Supratentorial (Group 1)

Patients undergo observation.
Experimental: Radiation (Group 2)

Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.

Radiation: radiation therapy
Given once daily 5 days a week for 6-6½ weeks
Other Names:
  • irradiation, radiotherapy, therapy, radiation

    		•
    Experimental: Sub-Total Resection Any Histology or Location (STR) (Group 3)

    Patients receive an initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.

    Biological: filgrastim
    Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
    Other Names:
  • G CSF, G-CSF, granulocyte colony stimulating factor, granulocyte colony-stimulating factor

    • Drug: carboplatin
    Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA <0.45m2 the dose is 12.5 mg/kg/day.
    Other Names:
  • Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA,

    • Drug: cyclophosphamide
    Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.
    Other Names:
  • Neosar, Procytox, Sendoxan, Syklofosfamid, WR-138719, Zytoxan

    • Drug: etoposide
    Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA < 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.
    Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, epipodophyllotoxin, Lastet, Toposar, VePesid

    • Drug: vincristine sulfate
    Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA<0.45m2 the dose is 0.05mg/kg.
    Other Names:
  • 22-oxovincaleukoblastine, 57-22-7, leurocristine sulfate, VCR, Vincasar PFS

    • Radiation: radiation therapy
    Given once daily 5 days a week for 6-6½ weeks
    Other Names:
  • irradiation, radiotherapy, therapy, radiation

    • Drug: Mesna
    Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.

    Procedure: therapeutic conventional surgery

    Outcome Measures

    Primary Outcome Measures

    1. Event-free Survival [Up to 5 years after completion of study treatment]

      Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.

    Secondary Outcome Measures

    1. Overall Survival [Up to 5 years after completion of study treatment]

      Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.

    2. Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy [At the time of second surgery]

      The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.

    3. Event-free Survival (EFS) [At 5 years since the time of radiation therapy.]

      EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.

    4. Event-free Survival (EFS) [At 5 years since the time of radiation therapy]

      EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.

    5. Local Control and Patterns of Failure [Up to 5 years after completion of study treatment]

      Documented and analyzed qualitatively and quantitatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed intracranial ependymoma

    • Differentiated ependymoma or anaplastic ependymoma

    • No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma

    • No evidence of noncontiguous spread beyond primary site

    • Initial surgical resection within the past 56 days

    PATIENT CHARACTERISTICS:
    Age:
    • 1 to 21
    Performance status:
    • No restrictions
    Life expectancy:
    • At least 2 months
    Hematopoietic:
    • Not specified
    Hepatic:
    • Not specified
    Renal:
    • Not specified
    Other:

    • Able to undergo MRI

    • 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 or concurrent corticosteroids allowed
    Radiotherapy:
    • No prior radiotherapy
    Surgery:

    • See Disease Characteristics

    • More than 1 prior surgery allowed

    Other:
    • No other prior treatment for ependymoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham Alabama United States 35294
    2 Phoenix Children's Hospital Phoenix Arizona United States 85016-7710
    3 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    4 Southern California Permanente Medical Group Downey California United States 90242-2814
    5 Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California United States 92354
    6 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach California United States 90801
    7 Childrens Hospital Los Angeles Los Angeles California United States 90027
    8 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles California United States 90048-1865
    9 Children's Hospital Central California Madera California United States 93638-8762
    10 Children's Hospital & Research Center Oakland Oakland California United States 94609
    11 Children's Hospital of Orange County Orange California United States 92868
    12 Sutter Cancer Center Sacramento California United States 95816
    13 University of California Davis Cancer Center Sacramento California United States 95817
    14 Kaiser Permanente Medical Center - Oakland Sacramento California United States 95825
    15 Children's Hospital and Health Center - San Diego San Diego California United States 92123-4282
    16 UCSF Comprehensive Cancer Center San Francisco California United States 94115
    17 Stanford Comprehensive Cancer Center - Stanford Stanford California United States 94305
    18 Children's Hospital Cancer Center Denver Colorado United States 80218-1088
    19 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington Connecticut United States 06360-2875
    20 Alfred I. duPont Hospital for Children Wilmington Delaware United States 19803
    21 Children's National Medical Center Washington District of Columbia United States 20010-2970
    22 Lee Cancer Care of Lee Memorial Health System Fort Myers Florida United States 33901
    23 University of Florida Shands Cancer Center Gainesville Florida United States 32610-0232
    24 Nemours Children's Clinic Jacksonville Florida United States 32207
    25 Miami Children's Hospital Miami Florida United States 33155
    26 Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida United States 32803-1273
    27 Nemours Children's Clinic - Orlando Orlando Florida United States 32806
    28 Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola Florida United States 32504
    29 All Children's Hospital Saint Petersburg Florida United States 33701
    30 St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa Florida United States 33607
    31 Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach Florida United States 33407
    32 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
    33 MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia United States 30912-3730
    34 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    35 St. Luke's Mountain States Tumor Institute - Boise Boise Idaho United States 83712-6297
    36 Rush University Medical Center Chicago Illinois United States 60612
    37 Children's Memorial Hospital - Chicago Chicago Illinois United States 60614
    38 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    39 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153
    40 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
    41 Advocate Lutheran General Cancer Care Center Park Ridge Illinois United States 60068-1174
    42 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    43 Southern Illinois University School of Medicine Springfield Illinois United States 62794-9620
    44 St. Vincent Indianapolis Hospital Indianapolis Indiana United States 46260
    45 Blank Children's Hospital Des Moines Iowa United States 50309
    46 Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington Kentucky United States 40536-0293
    47 Kosair Children's Hospital Louisville Kentucky United States 40232
    48 CancerCare of Maine at Eastern Maine Medial Center Bangor Maine United States 04401
    49 Maine Children's Cancer Program at Barbara Bush Children's Hospital Scarborough Maine United States 04074-9308
    50 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    51 Floating Hospital for Children at Tufts - New England Medical Center Boston Massachusetts United States 02111
    52 Massachusetts General Hospital Boston Massachusetts United States 02114
    53 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts United States 02115
    54 C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor Michigan United States 48109-0286
    55 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    56 Hurley Medical Center Flint Michigan United States 48503
    57 Spectrum Health Hospital - Butterworth Campus Grand Rapids Michigan United States 49503-2560
    58 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
    59 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-5341
    60 Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan United States 48910
    61 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    62 University of Minnesota Cancer Center at University of Minnesota Minneapolis Minnesota United States 55455
    63 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    64 University of Mississippi Cancer Clinic Jackson Mississippi United States 39216-4505
    65 Children's Mercy Hospital Kansas City Missouri United States 64108
    66 Cardinal Glennon Children's Hospital Saint Louis Missouri United States 63104
    67 Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    68 Children's Hospital Omaha Nebraska United States 68114-4113
    69 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109-2306
    70 Hackensack University Medical Center Cancer Center Hackensack New Jersey United States 07601
    71 Overlook Hospital Morristown New Jersey United States 07962
    72 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    73 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    74 St. Joseph's Hospital and Medical Center Paterson New Jersey United States 07503
    75 University of New Mexico Cancer Research and Treatment Center Albuquerque New Mexico United States 87131-5636
    76 Albany Medical Center Hospital Albany New York United States 12208-3419
    77 Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx New York United States 10461
    78 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    79 Schneider Children's Hospital New Hyde Park New York United States 11040
    80 NYU Cancer Institute at New York University Medical Center New York New York United States 10016
    81 Memorial Sloan - Kettering Cancer Center New York New York United States 10021-6094
    82 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York New York United States 10032
    83 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
    84 SUNY Upstate Medical University Hospital Syracuse New York United States 13210
    85 New York Medical College Valhalla New York United States 10595
    86 Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina United States 28232-2861
    87 Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina United States 28233-3549
    88 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    89 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
    90 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
    91 Children's Hospital Medical Center of Akron Akron Ohio United States 44308-1062
    92 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229-3039
    93 Rainbow Babies and Children's Hospital Cleveland Ohio United States 44106-5000
    94 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    95 Columbus Children's Hospital Columbus Ohio United States 43205-2696
    96 Children's Medical Center - Dayton Dayton Ohio United States 45404-1815
    97 Toledo Hospital Toledo Ohio United States 43606
    98 Medical University of Ohio Cancer Center Toledo Ohio United States 43614
    99 Tod Children's Hospital Youngstown Ohio United States 44501
    100 Oklahoma University Cancer Institute Oklahoma City Oklahoma United States 73104
    101 Legacy Emanuel Hospital and Health Center & Children's Hospital Portland Oregon United States 97227
    102 Geisinger Medical Center Danville Pennsylvania United States 17822-0001
    103 Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    104 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104-9786
    105 St. Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134-1095
    106 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    107 Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island United States 02903
    108 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
    109 Greenville Hospital System Cancer Center Greenville South Carolina United States 29605
    110 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
    111 T.C. Thompson Children's Hospital Chattanooga Tennessee United States 37403
    112 East Tennessee Children's Hospital Knoxville Tennessee United States 37901
    113 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    114 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    115 Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo Texas United States 79106
    116 Children's Hospital of Austin Austin Texas United States 78701
    117 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    118 Medical City Dallas Hospital Dallas Texas United States 75230
    119 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas United States 75390
    120 Cook Children's Medical Center - Fort Worth Fort Worth Texas United States 76104
    121 Baylor University Medical Center - Houston Houston Texas United States 77030-2399
    122 M. D. Anderson Cancer Center at University of Texas Houston Texas United States 77030-4009
    123 Covenant Children's Hospital Lubbock Texas United States 79410
    124 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229-3993
    125 CCOP - Scott and White Hospital Temple Texas United States 76508
    126 Primary Children's Medical Center Salt Lake City Utah United States 84113-1100
    127 Fletcher Allen Health Care - University Health Center Campus Burlington Vermont United States 05401
    128 INOVA Fairfax Hospital Falls Church Virginia United States 22042-3300
    129 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507-1971
    130 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
    131 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298-0037
    132 Carilion Cancer Center of Western Virginia Roanoke Virginia United States 24029
    133 Children's Hospital and Regional Medical Center - Seattle Seattle Washington United States 98105
    134 Providence Cancer Center at Sacred Heart Medical Center Spokane Washington United States 99220-2555
    135 West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston West Virginia United States 25302
    136 Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington West Virginia United States 25701
    137 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
    138 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
    139 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449
    140 Midwest Children's Cancer Center Milwaukee Wisconsin United States 53226
    141 John Hunter Hospital Newcastle New South Wales Australia 2310
    142 Prince of Wales Private Hospital Randwick New South Wales Australia 2031
    143 Westmead Institute for Cancer Research at Westmead Hospital Westmead New South Wales Australia 2145
    144 Royal Children's Hospital Herston, Brisbane Queensland Australia 4029
    145 Women's and Children's Hospital North Adelaide South Australia Australia 5006
    146 Royal Children's Hospital Parkville Victoria Australia 3052
    147 Princess Margaret Hospital for Children Perth Western Australia Australia 6001
    148 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
    149 University of Alberta Hospital Edmonton Alberta Canada T6G 1Z2
    150 Children's & Women's Hospital of British Columbia Vancouver British Columbia Canada V6H 3V4
    151 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    152 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
    153 McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
    154 Children's Hospital of Western Ontario London Ontario Canada N6A 4G5
    155 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    156 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    157 Hopital Sainte Justine Montreal Quebec Canada H3T 1C5
    158 Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan Canada S4T 7T1
    159 Saskatoon Cancer Centre at the University of Saskatchewan Saskatoon Saskatchewan Canada S7N 4H4
    160 Centre Hospitalier Universitaire de Quebec Quebec Canada G1V 4G2
    161 University Medical Center Groningen Groningen Netherlands 9713 EZ
    162 Starship Children's Health Auckland New Zealand 1
    163 Swiss Pediatric Oncology Group Bern Bern Switzerland 3010
    164 Swiss Pediatric Oncology Group Geneva Geneva Switzerland 1205
    165 Swiss Pediatric Oncology Group Lausanne Lausanne Switzerland 1011

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Thomas E. Merchant, DO, PhD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00027846
    Other Study ID Numbers:
    • ACNS0121
    • CDR0000069086
    • NCI-2012-02431
    • COG-ACNS0121
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Aug 7, 2019
    Last Verified:
    Jan 1, 2017
    Keywords provided by Children's Oncology Group
    childhood supratentorial ependymoma
    newly diagnosed childhood ependymoma
    childhood infratentorial ependymoma
    Additional relevant MeSH terms:
    Ependymoma
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Cyclophosphamide
    Carboplatin
    Etoposide
    Vincristine
    Podophyllotoxin
    Lenograstim

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title GTR1 Differentiated Histology Supratentorial (Group 1) Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Arm/Group Description Patients undergo observation. Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    Period Title: Overall Study
    STARTED 13 287 78
    COMPLETED 11 219 41
    NOT COMPLETED 2 68 37

    Baseline Characteristics

    Arm/Group Title GTR1 Differentiated Histology Supratentorial (Group 1) Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3) Total
    Arm/Group Description Patients undergo observation. Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient Total of all reporting groups
    Overall Participants 13 287 78 378
    Age (Count of Participants)
    <=18 years
    13
    100%
    281
    97.9%
    76
    97.4%
    370
    97.9%
    Between 18 and 65 years
    0
    0%
    6
    2.1%
    2
    2.6%
    8
    2.1%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    10.78
    5.58
    5.18
    5.60
    Sex: Female, Male (Count of Participants)
    Female
    7
    53.8%
    114
    39.7%
    38
    48.7%
    159
    42.1%
    Male
    6
    46.2%
    173
    60.3%
    40
    51.3%
    219
    57.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    36
    12.5%
    16
    20.5%
    52
    13.8%
    Not Hispanic or Latino
    10
    76.9%
    242
    84.3%
    59
    75.6%
    311
    82.3%
    Unknown or Not Reported
    3
    23.1%
    9
    3.1%
    3
    3.8%
    15
    4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    1
    1.3%
    1
    0.3%
    Asian
    0
    0%
    15
    5.2%
    6
    7.7%
    21
    5.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    2
    0.7%
    0
    0%
    2
    0.5%
    Black or African American
    1
    7.7%
    34
    11.8%
    4
    5.1%
    39
    10.3%
    White
    9
    69.2%
    219
    76.3%
    62
    79.5%
    290
    76.7%
    More than one race
    0
    0%
    3
    1%
    0
    0%
    3
    0.8%
    Unknown or Not Reported
    3
    23.1%
    14
    4.9%
    5
    6.4%
    22
    5.8%
    Region of Enrollment (participants) [Number]
    Canada
    1
    7.7%
    28
    9.8%
    8
    10.3%
    37
    9.8%
    Netherlands
    0
    0%
    6
    2.1%
    3
    3.8%
    9
    2.4%
    United States
    12
    92.3%
    243
    84.7%
    62
    79.5%
    317
    83.9%
    Australia
    0
    0%
    10
    3.5%
    5
    6.4%
    15
    4%

    Outcome Measures

    1. Primary Outcome
    Title Event-free Survival
    Description Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.
    Time Frame Up to 5 years after completion of study treatment

    Outcome Measure Data

    Analysis Population Description
    The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.
    Arm/Group Title GTR1 Differentiated Histology Supratentorial (Group 1) Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Arm/Group Description Patients undergo observation. Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    Measure Participants 11 281 64
    Number (95% Confidence Interval) [Probability of EFS at 5 years]
    0.614
    0.685
    0.372
    2. Secondary Outcome
    Title Overall Survival
    Description Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.
    Time Frame Up to 5 years after completion of study treatment

    Outcome Measure Data

    Analysis Population Description
    All eligible patients in the study were included. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability.
    Arm/Group Title GTR1 Differentiated Histology Supratentorial (Group 1) Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Arm/Group Description Patients undergo observation. Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    Measure Participants 11 281 64
    Number (95% Confidence Interval) [Probability of OS at 5 years]
    1
    0.862
    0.702
    3. Secondary Outcome
    Title Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy
    Description The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.
    Time Frame At the time of second surgery

    Outcome Measure Data

    Analysis Population Description
    Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.
    Arm/Group Title Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Arm/Group Description Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    Measure Participants 25
    Number (95% Confidence Interval) [percentage of participants]
    76
    584.6%
    4. Secondary Outcome
    Title Event-free Survival (EFS)
    Description EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.
    Time Frame At 5 years since the time of radiation therapy.

    Outcome Measure Data

    Analysis Population Description
    Of 64 eligible patients who had initial subtotal resection, 5 patients were off-therapy prior to radiation therapy, and 4 patients had a disease progression prior to radiation therapy. There were 55 eligible patients included in the analysis. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.
    Arm/Group Title Differentiated Ependymoma Anaplastic Ependymoma
    Arm/Group Description Differentiated ependymoma:tumor pathology by central review. Anaplastic ependymoma:tumor pathology by central review.
    Measure Participants 41 14
    Number (95% Confidence Interval) [Probability of EFS at 5 years]
    0.424
    0.298
    5. Secondary Outcome
    Title Event-free Survival (EFS)
    Description EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.
    Time Frame At 5 years since the time of radiation therapy

    Outcome Measure Data

    Analysis Population Description
    Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
    Arm/Group Title Differentiated Ependymoma Anaplastic Ependymoma
    Arm/Group Description Differentiated ependymoma:tumor pathology by central review. Anaplastic ependymoma:tumor pathology by central review.
    Measure Participants 157 124
    Number (95% Confidence Interval) [Probability of EFS at 5 years]
    0.746
    0.607
    6. Secondary Outcome
    Title Local Control and Patterns of Failure
    Description Documented and analyzed qualitatively and quantitatively.
    Time Frame Up to 5 years after completion of study treatment

    Outcome Measure Data

    Analysis Population Description
    All eligible patients in the study were included.
    Arm/Group Title GTR1 Differentiated Histology Supratentorial (Group 1) Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Arm/Group Description Patients undergo observation. Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    Measure Participants 11 281 64
    Local control
    6
    217
    29
    Pattern of failure local
    4
    57
    31
    Pattern of failure Metastatic
    0
    26
    5
    Pattern of failure local & metastatic
    1
    7
    4

    Adverse Events

    Time Frame
    Adverse Event Reporting Description All eligible patients were considered in the evaluation of adverse events. 281 eligible patients were in the group 2 and 64 eligible patients were in the group 3. GTR1 Differentiated Histology Supratentorial (Group 1) is an observation arm. Adverse events were not collected for the " GTR1 Differential Histology Supratentorial(Group 1)" observation arm..
    Arm/Group Title Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Arm/Group Description Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    All Cause Mortality
    Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 38/281 (13.5%) 55/64 (85.9%)
    Blood and lymphatic system disorders
    Hemoglobin (Hgb) 0/281 (0%) 0 28/64 (43.8%) 31
    Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other) 0/281 (0%) 0 1/64 (1.6%) 2
    Transfusion: Platelets 0/281 (0%) 0 10/64 (15.6%) 11
    Transfusion: pRBCs 1/281 (0.4%) 1 14/64 (21.9%) 17
    Febrile neutropenia (fever unknown origin no clinically or microbiologically documented infection) 1/281 (0.4%) 1 12/64 (18.8%) 13
    Cardiac disorders
    Cardiovascular/General - Other (Specify) 1/281 (0.4%) 1 0/64 (0%) 0
    Ear and labyrinth disorders
    Inner ear/hearing 0/281 (0%) 0 1/64 (1.6%) 1
    Eye disorders
    Ocular/Visual - Other (Specify) 0/281 (0%) 0 1/64 (1.6%) 1
    Gastrointestinal disorders
    Constipation 0/281 (0%) 0 1/64 (1.6%) 1
    Diarrhea (without colostomy) 0/281 (0%) 0 2/64 (3.1%) 2
    Dysphagia, esophagitis, odynophagia (painful swallowing) 1/281 (0.4%) 1 1/64 (1.6%) 1
    Nausea 0/281 (0%) 0 1/64 (1.6%) 1
    Typhlitis (inflammation of cecum) 0/281 (0%) 0 1/64 (1.6%) 1
    Vomiting 1/281 (0.4%) 1 4/64 (6.3%) 4
    Gastrointestinal - Other (Specify) 1/281 (0.4%) 1 0/64 (0%) 0
    Abdominal pain or cramping 0/281 (0%) 0 1/64 (1.6%) 1
    General disorders
    Constitutional Symptoms - Other (Specify) 1/281 (0.4%) 1 1/64 (1.6%) 1
    Irritability (<3yrs of age) 0/281 (0%) 0 1/64 (1.6%) 1
    Infections and infestations
    Wound-infectious 1/281 (0.4%) 1 3/64 (4.7%) 3
    Catheter-related infection 1/281 (0.4%) 1 3/64 (4.7%) 5
    Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia 2/281 (0.7%) 2 10/64 (15.6%) 10
    Infection with unknown ANC 1/281 (0.4%) 1 3/64 (4.7%) 4
    Infection without neutropenia 9/281 (3.2%) 9 10/64 (15.6%) 13
    Injury, poisoning and procedural complications
    Radiation dermatitis 1/281 (0.4%) 1 0/64 (0%) 0
    Investigations
    Leukocytes (total WBC) 4/281 (1.4%) 4 40/64 (62.5%) 47
    Lymphopenia 8/281 (2.8%) 8 15/64 (23.4%) 18
    Neutrophils/granulocytes (ANC/AGC) 6/281 (2.1%) 6 40/64 (62.5%) 49
    Platelets 0/281 (0%) 0 25/64 (39.1%) 28
    Partial thromboplastin time (PTT) 0/281 (0%) 0 2/64 (3.1%) 2
    Alkaline phosphatase 1/281 (0.4%) 1 0/64 (0%) 0
    SGOT (AST) 1/281 (0.4%) 1 0/64 (0%) 0
    SGPT (ALT) 1/281 (0.4%) 1 1/64 (1.6%) 2
    Amylase 0/281 (0%) 0 1/64 (1.6%) 1
    Lipase 0/281 (0%) 0 1/64 (1.6%) 9
    Metabolism and nutrition disorders
    Anorexia 2/281 (0.7%) 2 3/64 (4.7%) 3
    Dehydration 0/281 (0%) 0 2/64 (3.1%) 2
    Hyperglycemia 0/281 (0%) 0 1/64 (1.6%) 1
    Hyperkalemia 0/281 (0%) 0 1/64 (1.6%) 1
    Hypernatremia 0/281 (0%) 0 1/64 (1.6%) 1
    Hypocalcemia 0/281 (0%) 0 1/64 (1.6%) 1
    Hypokalemia 0/281 (0%) 0 2/64 (3.1%) 2
    Nervous system disorders
    Ataxia (incoordination) 0/281 (0%) 0 1/64 (1.6%) 1
    Depressed level of consciousness 1/281 (0.4%) 1 1/64 (1.6%) 1
    Extrapyramidal/involuntary movement/restlessness 0/281 (0%) 0 1/64 (1.6%) 1
    Neuropathy - cranial 2/281 (0.7%) 2 0/64 (0%) 0
    Neuropathy - motor 1/281 (0.4%) 1 0/64 (0%) 0
    Seizure(s) 3/281 (1.1%) 3 2/64 (3.1%) 2
    Neurology - Other (Specify) 0/281 (0%) 0 1/64 (1.6%) 1
    Headache 2/281 (0.7%) 2 1/64 (1.6%) 1
    Psychiatric disorders
    Hallucinations 1/281 (0.4%) 1 0/64 (0%) 0
    Mood alteration-anxiety, agitation 1/281 (0.4%) 1 1/64 (1.6%) 1
    Mood alteration-depression 1/281 (0.4%) 1 0/64 (0%) 0
    Personality/behavioral 2/281 (0.7%) 2 0/64 (0%) 0
    Renal and urinary disorders
    Incontinence 1/281 (0.4%) 1 0/64 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Apnea 1/281 (0.4%) 1 3/64 (4.7%) 4
    Hypoxia 0/281 (0%) 0 2/64 (3.1%) 2
    Pulmonary - Other (Specify) 1/281 (0.4%) 1 0/64 (0%) 0
    Vascular disorders
    Hypertension 0/281 (0%) 0 1/64 (1.6%) 1
    Thrombosis/embolism 0/281 (0%) 0 1/64 (1.6%) 2
    Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia 1/281 (0.4%) 2 0/64 (0%) 0
    Other (Not Including Serious) Adverse Events
    Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 52/281 (18.5%) 27/64 (42.2%)
    Blood and lymphatic system disorders
    Hemoglobin (Hgb) 0/281 (0%) 0 5/64 (7.8%) 5
    Gastrointestinal disorders
    Constipation 0/281 (0%) 0 6/64 (9.4%) 6
    Nausea 0/281 (0%) 0 5/64 (7.8%) 6
    Vomiting 19/281 (6.8%) 19 7/64 (10.9%) 9
    General disorders
    Fatigue (lethargy, malaise, asthenia) 0/281 (0%) 0 6/64 (9.4%) 9
    Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L) 0/281 (0%) 0 5/64 (7.8%) 6
    Investigations
    Leukocytes (total WBC) 16/281 (5.7%) 18 8/64 (12.5%) 9
    Platelets 0/281 (0%) 0 7/64 (10.9%) 7
    Weight loss 0/281 (0%) 0 4/64 (6.3%) 4
    SGOT (AST) 0/281 (0%) 0 6/64 (9.4%) 6
    SGPT (ALT) 0/281 (0%) 0 7/64 (10.9%) 8
    Metabolism and nutrition disorders
    Anorexia 0/281 (0%) 0 4/64 (6.3%) 5
    Hyperglycemia 0/281 (0%) 0 5/64 (7.8%) 5
    Hypocalcemia 0/281 (0%) 0 5/64 (7.8%) 5
    Hyponatremia 0/281 (0%) 0 4/64 (6.3%) 5
    Skin and subcutaneous tissue disorders
    Alopecia 17/281 (6%) 17 0/64 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Must obtain sponsor approval.

    Results Point of Contact

    Name/Title Results Reporting Coordinator
    Organization Children's Oncology Group
    Phone 626-447-0064
    Email resultsreportingcoordinator@childrensoncologygroup.org
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00027846
    Other Study ID Numbers:
    • ACNS0121
    • CDR0000069086
    • NCI-2012-02431
    • COG-ACNS0121
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Aug 7, 2019
    Last Verified:
    Jan 1, 2017