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Trial record 4 of 6 for:    "Germinoma" | "Antibiotics, Antitubercular"

Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT00053352
Recruitment Status : Completed
First Posted : January 28, 2003
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
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 Childhood Embryonal Tumor
Childhood Extracranial Germ Cell Tumor
Childhood Extragonadal Germ Cell Tumor
Childhood Malignant Ovarian Germ Cell Tumor
Childhood Malignant Testicular Germ Cell Tumor
Childhood Teratoma
Ovarian Embryonal Carcinoma
Ovarian Yolk Sac Tumor
Stage II Malignant Testicular Germ Cell Tumor
Stage IIA Ovarian Germ Cell Tumor
Stage IIB Ovarian Germ Cell Tumor
Stage IIC Ovarian Germ Cell Tumor
Stage III Malignant Testicular Germ Cell Tumor
Stage IIIA Ovarian Germ Cell Tumor
Stage IIIB Ovarian Germ Cell Tumor
Stage IIIC Ovarian Germ Cell Tumor
Testicular Choriocarcinoma and Yolk Sac Tumor
Testicular Embryonal Carcinoma
Interventions Procedure: conventional surgery
Drug: cisplatin
Drug: etoposide
Biological: bleomycin sulfate
Other: laboratory biomarker analysis
Enrollment 302
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Arm 2
Hide Arm/Group Description Experimental No intervention
Period Title: Overall Study
Started 190 112
Completed 169 102
Not Completed 21 10
Reason Not Completed
Lost to Follow-up             0             1
Physician Decision             11             1
Withdrawal by Subject             1             0
Ineligible             8             8
Disease at new site             1             0
Arm/Group Title Arm I Arm 2 Total
Hide Arm/Group Description Experimental No intervention Total of all reporting groups
Overall Number of Baseline Participants 190 112 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 112 participants 302 participants
9.57  (5.65) 5.41  (5.93) 8.02  (6.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 112 participants 302 participants
Female
145
  76.3%
29
  25.9%
174
  57.6%
Male
45
  23.7%
83
  74.1%
128
  42.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 112 participants 302 participants
American Indian or Alaska Native
1
   0.5%
1
   0.9%
2
   0.7%
Asian
14
   7.4%
10
   8.9%
24
   7.9%
Native Hawaiian or Other Pacific Islander
1
   0.5%
3
   2.7%
4
   1.3%
Black or African American
22
  11.6%
8
   7.1%
30
   9.9%
White
128
  67.4%
72
  64.3%
200
  66.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
24
  12.6%
18
  16.1%
42
  13.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 190 participants 112 participants 302 participants
New Zealand 2 3 5
Canada 16 8 24
United States 170 91 261
Australia 1 8 9
Switzerland 0 2 2
Guam 1 0 1
1.Primary Outcome
Title Event-Free Survival (EFS)
Hide Description Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.
Time Frame 3 Years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
181 patients were evaluated for event free survival through 3 years for patients enrolled on Arm 1. Event-free survival is not a primary outcome measure for Arm 2 patients.
Arm/Group Title Arm 1
Hide Arm/Group Description:
Experimental
Overall Number of Participants Analyzed 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent probability
87.0
(81.0 to 92.0)
2.Primary Outcome
Title Overall Survival (OS)
Hide Description Percentage probability of being alive at 3 years following enrollment.
Time Frame 3 Years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm 2
Hide Arm/Group Description:
Experimental
No intervention
Overall Number of Participants Analyzed 181 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent Probability
97.0
(93.0 to 99.0)
99.0
(92.8 to 99.9)
3.Secondary Outcome
Title Days Hospitalized for Patients Who Receive Chemotherapy
Hide Description Calculated to quantify the treatment cost associated with this regimen.
Time Frame Up to 126 days after the start of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint
Arm/Group Title Arm I
Hide Arm/Group Description:
Experimental
Overall Number of Participants Analyzed 182
Mean (Standard Deviation)
Unit of Measure: Days in the hospital
14.08  (10.27)
4.Secondary Outcome
Title Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Hide Description The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy
Time Frame Up to 126 days after the start of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint
Arm/Group Title Arm I
Hide Arm/Group Description:
Experimental
Overall Number of Participants Analyzed 182
Measure Type: Number
Unit of Measure: patients
Abdominal pain 3
Acute kidney injury 1
Lymphocyte count decrease 2
Iincrease in alanine aminotransferase 1
Neutrophil count decrease 58
Anemia 10
Increase in aspartate aminotransferase 1
Catheter related infection 1
Constipation 1
Dehydration 1
Encephalopathy 1
Febrile neutropenia 9
Fever 3
Hyperglycemia 1
Hyperkalemia 1
Hypocalcemia 2
Hypokalemia 1
Hypomagnesemia 1
Hyponatremia 1
Hypophosphatemia 6
Small intestine obstruction 1
Nausea 5
Non-cardiac chest pain 1
Other gastrointestinal disorders 1
Other infection 10
Platelet count decrease 7
Syncope 1
Vomiting 4
White blood cell decrease 17
Wound infection 1
Time Frame [Not Specified]
Adverse Event Reporting Description Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title “No Intervention” (Arm/Group Description: “Arm 2”) 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title “Experimental” (Arm/Group Description: “Arm 1”) 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
 
Arm/Group Title Arm 2 (Observation) Arm I (Chemotherapy)
Hide Arm/Group Description

Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm.

Observation only for recurrence or development of an SMN

Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes & etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 & 6).

After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (2nd-look) and/or 3 more courses of compressed consolidation chemotherapy.

After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.

Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, & 16.

con

All-Cause Mortality
Arm 2 (Observation) Arm I (Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 2 (Observation) Arm I (Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)   0/182 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 2 (Observation) Arm I (Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)   78/182 (42.86%) 
Blood and lymphatic system disorders     
Anemia  0/104 (0.00%)  10/182 (5.49%) 
Febrile neutropenia  0/104 (0.00%)  9/182 (4.95%) 
Ear and labyrinth disorders     
Hearing impaired  0/104 (0.00%)  1/182 (0.55%) 
Gastrointestinal disorders     
Abdominal pain  0/104 (0.00%)  3/182 (1.65%) 
Constipation  0/104 (0.00%)  1/182 (0.55%) 
Gastrointestinal disorders - Other, specify  0/104 (0.00%)  1/182 (0.55%) 
Ileus  0/104 (0.00%)  0/182 (0.00%) 
Nausea  0/104 (0.00%)  5/182 (2.75%) 
Small intestinal obstruction  0/104 (0.00%)  1/182 (0.55%) 
Vomiting  0/104 (0.00%)  4/182 (2.20%) 
General disorders     
Fever  0/104 (0.00%)  3/182 (1.65%) 
Non-cardiac chest pain  0/104 (0.00%)  1/182 (0.55%) 
Infections and infestations     
Catheter related infection  0/104 (0.00%)  1/182 (0.55%) 
Infections and infestations - Other, specify  0/104 (0.00%)  10/182 (5.49%) 
Urinary tract infection  0/104 (0.00%)  0/182 (0.00%) 
Wound infection  0/104 (0.00%)  1/182 (0.55%) 
Investigations     
Alanine aminotransferase increased  0/104 (0.00%)  1/182 (0.55%) 
Aspartate aminotransferase increased  0/104 (0.00%)  1/182 (0.55%) 
Lymphocyte count decreased  0/104 (0.00%)  2/182 (1.10%) 
Neutrophil count decreased  0/104 (0.00%)  58/182 (31.87%) 
Platelet count decreased  0/104 (0.00%)  7/182 (3.85%) 
White blood cell decreased  0/104 (0.00%)  17/182 (9.34%) 
Metabolism and nutrition disorders     
Dehydration  0/104 (0.00%)  1/182 (0.55%) 
Hyperglycemia  0/104 (0.00%)  1/182 (0.55%) 
Hyperkalemia  0/104 (0.00%)  1/182 (0.55%) 
Hypocalcemia  0/104 (0.00%)  2/182 (1.10%) 
Hypokalemia  0/104 (0.00%)  1/182 (0.55%) 
Hypomagnesemia  0/104 (0.00%)  1/182 (0.55%) 
Hyponatremia  0/104 (0.00%)  1/182 (0.55%) 
Hypophosphatemia  0/104 (0.00%)  6/182 (3.30%) 
Nervous system disorders     
Encephalopathy  0/104 (0.00%)  1/182 (0.55%) 
Syncope  0/104 (0.00%)  1/182 (0.55%) 
Renal and urinary disorders     
Acute kidney injury  0/104 (0.00%)  1/182 (0.55%) 
Only patients considered eligible contribute to the tabulation of AEs. Arm 1: 182 eligible as described in Participant Flow as 190 enrolled, -8 ineligible. Arm 2: 104 eligible as described in Participant Flow as 112 enrolled, -8 ineligible.
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 prior Sponsor approval.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00053352     History of Changes
Other Study ID Numbers: AGCT0132
NCI-2009-00373 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000269433 ( Other Identifier: Clinical Trials.gov )
COG-AGCT0132 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2003
First Posted: January 28, 2003
Results First Submitted: July 11, 2016
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017