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Type(s) of Cancer
Germ Cell
Study Phase
Phase 3
Study Completion Date
2013-10-01
NCT00053352Uploaded 04-28-2020
Access via NCI by Request
PDS UID: nci-data-410
A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors
Provider Information
Provider Data DescriptionNCT00053352-D1 The dataset provides the information for the consort diagram (Figure 1). There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.
ConditionsChildhood 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
Intervention TypeProcedure: conventional surgery
Drug: cisplatin
Drug: etoposide
Biological: bleomycin sulfate
Other: laboratory biomarker analysis
Drug(s)Drug: cisplatin
Drug: etoposide
Total Enrolled302
RandomizationNon Randomized
Blinding MethodNone
Arms InterventionArm I - Experimental
Arm 2 - No Intervention
Secondary IDNCI-2009-00373
PubMed (PMID)31355926
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range21 Years and younger (CHILD, ADULT)
Files: NCT00053352-D1
Data DictionaryNCT00053352-D1-Data-Dictionary_1.pdf
DATANCT00053352-D1-Dataset.CSV
OTHERREADME.pdf
Files: NCT00053352-D2
Data DictionaryNCT00053352-D2-Data-Dictionary_1.pdf
DATANCT00053352-D2-Dataset.CSV
OTHERREADME.pdf
Files: NCT00053352-D3
Data DictionaryNCT00053352-D3-Data-Dictionary_1.pdf
DATANCT00053352-D3-Dataset.CSV
OTHERREADME.pdf
Files: NCT00053352-D4
Data DictionaryNCT00053352-D4-Data-Dictionary_1.pdf
DATANCT00053352-D4-Dataset.CSV
OTHERREADME.pdf
Files: NCT00053352-D5
Data DictionaryNCT00053352-D5-Data-Dictionary_2.pdf
DATANCT00053352-D5-Dataset_1.csv
OTHERREADME.pdf
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