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Germ Cell

A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

Unique Dataset IDnci-data-410ClinicalTrial.gov IDNCT00053352
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients302RandomizationNoPubMed (PMID)28240974.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeSurgery, Biologics, Other, Drug, ChemotherapyDataset TypeOther

Clinical Trial Title

A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

Trial Summary and Conditions

This 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.

Data Summary

See Data Dictionary.

Study Objectives

OBJECTIVES: I. Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin, etoposide, and bleomycin (low-risk disease closed to accrual as of 01/20/10); II. Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated; III. Determine the percentage of intermediate-risk patients who require only 3 courses of therapy; IV. Determine the acute toxic effects of compressed therapy in these patients; V. Determine the long-term sequelae in patients treated with this regimen; VI. Determine the number of hospital days and total drug doses required for patients treated with compressed therapy; VII. Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study; VIII. Determine the cytogenetic and molecular genetic features in patients treated with this regimen.

Outcome Measures

PRIMARY OUTCOME MEASURES: 1. Event-free Survival (EFS); 2. Overall Survival (OS). SECONDARY OUTCOME MEASURES: 1. Days Hospitalized for Patients Who Receive Chemotherapy; 2. Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

NCT00053352-D1 The dataset provides the information for the consort diagram (Figure 1). There is one row per patient.

Available Downloads: NCT00053352-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00053352-D1-Data-Dictionary_1.pdf

DATA: NCT00053352-D1-Dataset.CSV

OTHER: README.pdf

Available Downloads: NCT00053352-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00053352-D2-Data-Dictionary_1.pdf

DATA: NCT00053352-D2-Dataset.CSV

OTHER: README.pdf

Available Downloads: NCT00053352-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00053352-D3-Data-Dictionary_1.pdf

DATA: NCT00053352-D3-Dataset.CSV

OTHER: README.pdf

Available Downloads: NCT00053352-D4

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00053352-D4-Data-Dictionary_1.pdf

DATA: NCT00053352-D4-Dataset.CSV

OTHER: README.pdf

Available Downloads: NCT00053352-D5

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00053352-D5-Data-Dictionary_2.pdf

DATA: NCT00053352-D5-Dataset_1.csv

OTHER: README.pdf