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Sarcoma

Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma

Unique Dataset IDnci-data-94ClinicalTrial.gov IDNCT00354744
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients0RandomizationNoPubMed (PMID)26503200.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeBiological, Surgery, Drug, RadiationDataset TypeOther

NCI Description

NCT00354744-D2 This dataset contains incidence of adverse events as reported in the manuscript.

Clinical Trial Title

Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.

Data Summary

See data dictionary for more details.

Study Objectives

Primary: Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression therapy (comprising vincristine, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin) that permits maximal early exposure to known effective agents. Determine the feasibility of concurrent irinotecan hydrochloride and radiotherapy in these patients. Assess immediate- and short-term side effects of concurrent irinotecan hydrochloride and radiotherapy in these patients. Secondary: Expand the available data for response to irinotecan hydrochloride and vincristine in previously untreated patients with high-risk rhabdomyosarcoma. Evaluate, prospectively, and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers. OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are stratified according to prognostic factors predictive of outcome (e.g. histology, bone/bone marrow involvement, and number of metastatic sites).

Outcome Measures

Primary: Tumor Response Rate [ Time Frame: Protocol week 6 evaluation ] Estimate of the Percent of Patients Event Free at 4 Years Following Study Entry [ Time Frame: 4 years ] Secondary: Early Disease Control [ Time Frame: 2 years ] Feasibility [ Time Frame: 2 years ] Toxicity [ Time Frame: 2 years ]

ClinicalTrial.gov

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

Available Downloads:

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

Data Dictionary: NCT00354744-D2-Data-Dictionary.pdf

DATA: NCT00354744-D2-Dataset.csv

OTHER: README.pdf