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

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ClinicalTrials.gov Identifier: NCT00027846
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : March 1, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain Tumor
Central Nervous System Tumor
Interventions Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: vincristine sulfate
Radiation: radiation therapy
Drug: Mesna
Procedure: therapeutic conventional surgery
Enrollment 378
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GTR1 Differentiated Histology Supratentorial (Group 1) Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
Hide 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
Reason Not Completed
Lost to Follow-up             0             41             9
Withdrawal by Subject             0             14             7
Ineligible for study             2             6             14
Entry into another COG therapeutic study             0             5             2
Neuraxis dissemination during/after ther             0             2             5
Arm/Group Title GTR1 Differentiated Histology Supratentorial (Group 1) Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3) Total
Hide 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 Number of Baseline Participants 13 287 78 378
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 287 participants 78 participants 378 participants
<=18 years
13
 100.0%
281
  97.9%
76
  97.4%
370
  97.9%
Between 18 and 65 years
0
   0.0%
6
   2.1%
2
   2.6%
8
   2.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 287 participants 78 participants 378 participants
10.78
(1.49 to 16.71)
5.58
(1.01 to 21.01)
5.18
(1.01 to 19.60)
5.60
(1.01 to 21.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 287 participants 78 participants 378 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 287 participants 78 participants 378 participants
Hispanic or Latino
0
   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
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 287 participants 78 participants 378 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.3%
Asian
0
   0.0%
15
   5.2%
6
   7.7%
21
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.7%
0
   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
   0.0%
3
   1.0%
0
   0.0%
3
   0.8%
Unknown or Not Reported
3
  23.1%
14
   4.9%
5
   6.4%
22
   5.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 287 participants 78 participants 378 participants
Canada 1 28 8 37
Netherlands 0 6 3 9
United States 12 243 62 317
Australia 0 10 5 15
1.Primary Outcome
Title Event-free Survival
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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

Overall Number of Participants Analyzed 11 281 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of EFS at 5 years
0.614
(0.33 to 0.90)
0.685
(0.63 to 0.74)
0.372
(0.25 to 0.50)
2.Secondary Outcome
Title Overall Survival
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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

Overall Number of Participants Analyzed 11 281 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of OS at 5 years
1
(1 to 1)
0.862
(0.82 to 0.91)
0.702
(0.58 to 0.82)
3.Secondary Outcome
Title Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy
Hide Description The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.
Time Frame At the time of second surgery
Hide Outcome Measure Data
Hide 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)
Hide 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

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76
(54.9 to 90.6)
4.Secondary Outcome
Title Event-free Survival (EFS)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Differentiated ependymoma:tumor pathology by central review.
Anaplastic ependymoma:tumor pathology by central review.
Overall Number of Participants Analyzed 41 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of EFS at 5 years
0.424
(0.27 to 0.58)
0.298
(0.05 to 0.54)
5.Secondary Outcome
Title Event-free Survival (EFS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Differentiated ependymoma:tumor pathology by central review.
Anaplastic ependymoma:tumor pathology by central review.
Overall Number of Participants Analyzed 157 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of EFS at 5 years
0.746
(0.68 to 0.82)
0.607
(0.51 to 0.70)
6.Secondary Outcome
Title Local Control and Patterns of Failure
Hide Description Documented and analyzed qualitatively and quantitatively.
Time Frame Up to 5 years after completion of study treatment
Hide Outcome Measure Data
Hide 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)
Hide 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

Overall Number of Participants Analyzed 11 281 64
Measure Type: Number
Unit of Measure: Participant
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
Time Frame [Not Specified]
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)
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide 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 (13.52%)      55/64 (85.94%)    
Blood and lymphatic system disorders     
Hemoglobin (Hgb)  0/281 (0.00%)  0 28/64 (43.75%)  31
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)  0/281 (0.00%)  0 1/64 (1.56%)  2
Transfusion: Platelets  0/281 (0.00%)  0 10/64 (15.63%)  11
Transfusion: pRBCs  1/281 (0.36%)  1 14/64 (21.88%)  17
Febrile neutropenia (fever unknown origin no clinically or microbiologically documented infection)  1/281 (0.36%)  1 12/64 (18.75%)  13
Cardiac disorders     
Cardiovascular/General - Other (Specify)  1/281 (0.36%)  1 0/64 (0.00%)  0
Ear and labyrinth disorders     
Inner ear/hearing  0/281 (0.00%)  0 1/64 (1.56%)  1
Eye disorders     
Ocular/Visual - Other (Specify)  0/281 (0.00%)  0 1/64 (1.56%)  1
Gastrointestinal disorders     
Constipation  0/281 (0.00%)  0 1/64 (1.56%)  1
Diarrhea (without colostomy)  0/281 (0.00%)  0 2/64 (3.13%)  2
Dysphagia, esophagitis, odynophagia (painful swallowing)  1/281 (0.36%)  1 1/64 (1.56%)  1
Nausea  0/281 (0.00%)  0 1/64 (1.56%)  1
Typhlitis (inflammation of cecum)  0/281 (0.00%)  0 1/64 (1.56%)  1
Vomiting  1/281 (0.36%)  1 4/64 (6.25%)  4
Gastrointestinal - Other (Specify)  1/281 (0.36%)  1 0/64 (0.00%)  0
Abdominal pain or cramping  0/281 (0.00%)  0 1/64 (1.56%)  1
General disorders     
Constitutional Symptoms - Other (Specify)  1/281 (0.36%)  1 1/64 (1.56%)  1
Irritability (<3yrs of age)  0/281 (0.00%)  0 1/64 (1.56%)  1
Infections and infestations     
Wound-infectious  1/281 (0.36%)  1 3/64 (4.69%)  3
Catheter-related infection  1/281 (0.36%)  1 3/64 (4.69%)  5
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia  2/281 (0.71%)  2 10/64 (15.63%)  10
Infection with unknown ANC  1/281 (0.36%)  1 3/64 (4.69%)  4
Infection without neutropenia  9/281 (3.20%)  9 10/64 (15.63%)  13
Injury, poisoning and procedural complications     
Radiation dermatitis  1/281 (0.36%)  1 0/64 (0.00%)  0
Investigations     
Leukocytes (total WBC)  4/281 (1.42%)  4 40/64 (62.50%)  47
Lymphopenia  8/281 (2.85%)  8 15/64 (23.44%)  18
Neutrophils/granulocytes (ANC/AGC)  6/281 (2.14%)  6 40/64 (62.50%)  49
Platelets  0/281 (0.00%)  0 25/64 (39.06%)  28
Partial thromboplastin time (PTT)  0/281 (0.00%)  0 2/64 (3.13%)  2
Alkaline phosphatase  1/281 (0.36%)  1 0/64 (0.00%)  0
SGOT (AST)  1/281 (0.36%)  1 0/64 (0.00%)  0
SGPT (ALT)  1/281 (0.36%)  1 1/64 (1.56%)  2
Amylase  0/281 (0.00%)  0 1/64 (1.56%)  1
Lipase  0/281 (0.00%)  0 1/64 (1.56%)  9
Metabolism and nutrition disorders     
Anorexia  2/281 (0.71%)  2 3/64 (4.69%)  3
Dehydration  0/281 (0.00%)  0 2/64 (3.13%)  2
Hyperglycemia  0/281 (0.00%)  0 1/64 (1.56%)  1
Hyperkalemia  0/281 (0.00%)  0 1/64 (1.56%)  1
Hypernatremia  0/281 (0.00%)  0 1/64 (1.56%)  1
Hypocalcemia  0/281 (0.00%)  0 1/64 (1.56%)  1
Hypokalemia  0/281 (0.00%)  0 2/64 (3.13%)  2
Nervous system disorders     
Ataxia (incoordination)  0/281 (0.00%)  0 1/64 (1.56%)  1
Depressed level of consciousness  1/281 (0.36%)  1 1/64 (1.56%)  1
Extrapyramidal/involuntary movement/restlessness  0/281 (0.00%)  0 1/64 (1.56%)  1
Neuropathy - cranial  2/281 (0.71%)  2 0/64 (0.00%)  0
Neuropathy - motor  1/281 (0.36%)  1 0/64 (0.00%)  0
Seizure(s)  3/281 (1.07%)  3 2/64 (3.13%)  2
Neurology - Other (Specify)  0/281 (0.00%)  0 1/64 (1.56%)  1
Headache  2/281 (0.71%)  2 1/64 (1.56%)  1
Psychiatric disorders     
Hallucinations  1/281 (0.36%)  1 0/64 (0.00%)  0
Mood alteration-anxiety, agitation  1/281 (0.36%)  1 1/64 (1.56%)  1
Mood alteration-depression  1/281 (0.36%)  1 0/64 (0.00%)  0
Personality/behavioral  2/281 (0.71%)  2 0/64 (0.00%)  0
Renal and urinary disorders     
Incontinence  1/281 (0.36%)  1 0/64 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnea  1/281 (0.36%)  1 3/64 (4.69%)  4
Hypoxia  0/281 (0.00%)  0 2/64 (3.13%)  2
Pulmonary - Other (Specify)  1/281 (0.36%)  1 0/64 (0.00%)  0
Vascular disorders     
Hypertension  0/281 (0.00%)  0 1/64 (1.56%)  1
Thrombosis/embolism  0/281 (0.00%)  0 1/64 (1.56%)  2
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1/281 (0.36%)  2 0/64 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radiation (Group 2) Sub-Total Resection Any Histology or Location (STR) (Group 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/281 (18.51%)      27/64 (42.19%)    
Blood and lymphatic system disorders     
Hemoglobin (Hgb)  0/281 (0.00%)  0 5/64 (7.81%)  5
Gastrointestinal disorders     
Constipation  0/281 (0.00%)  0 6/64 (9.38%)  6
Nausea  0/281 (0.00%)  0 5/64 (7.81%)  6
Vomiting  19/281 (6.76%)  19 7/64 (10.94%)  9
General disorders     
Fatigue (lethargy, malaise, asthenia)  0/281 (0.00%)  0 6/64 (9.38%)  9
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L)  0/281 (0.00%)  0 5/64 (7.81%)  6
Investigations     
Leukocytes (total WBC)  16/281 (5.69%)  18 8/64 (12.50%)  9
Platelets  0/281 (0.00%)  0 7/64 (10.94%)  7
Weight loss  0/281 (0.00%)  0 4/64 (6.25%)  4
SGOT (AST)  0/281 (0.00%)  0 6/64 (9.38%)  6
SGPT (ALT)  0/281 (0.00%)  0 7/64 (10.94%)  8
Metabolism and nutrition disorders     
Anorexia  0/281 (0.00%)  0 4/64 (6.25%)  5
Hyperglycemia  0/281 (0.00%)  0 5/64 (7.81%)  5
Hypocalcemia  0/281 (0.00%)  0 5/64 (7.81%)  5
Hyponatremia  0/281 (0.00%)  0 4/64 (6.25%)  5
Skin and subcutaneous tissue disorders     
Alopecia  17/281 (6.05%)  17 0/64 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00027846    
Other Study ID Numbers: ACNS0121
CDR0000069086 ( Other Identifier: Clinical Trials.gov )
NCI-2012-02431 ( Other Identifier: NCI )
COG-ACNS0121 ( Other Identifier: Children's Oncology Group )
First Submitted: December 7, 2001
First Posted: January 27, 2003
Results First Submitted: May 27, 2016
Results First Posted: March 1, 2017
Last Update Posted: August 7, 2019