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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
  2. After adding all desired datasets to your request, you must complete a request form accessible via the 'My Data Requests' link in your account profile. After submitting your data request form, your request will be delivered to NCI for approval.
  3. Once your request is approved, you will receive notice that you have access to the dataset(s) in SAS® Life Sciences Analytic Framework within the Project Data Sphere Cancer Research Platform and that you may download the dataset(s) onto a personal machine.

To be able to request access to this data and the other analytic tools click here.

NCT00354835

Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)

Unique Dataset IDnci-data-431ClinicalTrial.gov IDNCT00354835
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients0RandomizationN/APubMed (PMID)30091945.0
Study PhaseN/ABlinding MethodN/AType(s) of dataN/AIntervention TypeN/ADataset TypeN/A

Clinical Trial Title

Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)

Trial Summary and Conditions

N/A

Data Summary

N/A

Study Objectives

N/A

Outcome Measures

Primary:Event Free Survival (EFS) [ Time Frame: 4 years ]; Probability of no relapse, secondary malignancy, or death after 4 year in the study; Response Rate (RR) [ Time Frame: Reporting Period 1 (Weeks 1 - 15) ]; Proportion of patients with complete or partial response; Overall Survival (OS) [ Time Frame: 4 years ] Probability of being alive after 4 years in the study.Secondary:Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison [ Time Frame: 4 years ]; Local Failure [ Time Frame: 2 years ]; Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison [ Time Frame: 4 years ]; Incidence of Toxicity [ Time Frame: Up to 15 weeks ];Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC [ Time Frame: Up to 43 weeks ]

ClinicalTrial.gov

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

NCI Description

There are three datasets associated with PubMed ID 30091945: NCT00354835-D1, NCT00354835-D2, and NCT00354835-D3. Dataset NCT00354835-D1 is required for re-creating the main results of the manuscript. The data contains information including histology, group, adverse events, stage, EFS and OS, and demographics.

Available Downloads: NCT00354835-D1

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

Data Dictionary: NCT00354835-D1-Data-Dictionary_3.pdf

DATA: NCT00354835-D1-Dataset_3.csv

OTHER: README.pdf

Available Downloads: NCT00354835-D2

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

Data Dictionary: NCT00354835-D2-Data-Dictionary_4.pdf

DATA: NCT00354835-D2-Dataset_3.csv

OTHER: README.pdf

Available Downloads: NCT00354835-D3

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

Data Dictionary: NCT00354835-D3-Data-Dictionary_4.pdf

DATA: NCT00354835-D3-Dataset_2.csv

OTHER: README.pdf