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Type(s) of Cancer
Adult Malignant Mesenchymoma, Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Botryoid-Type Embryonal Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Childhood Malignant Mesenchymoma, Non-Metastatic Childhood Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Untreated Childhood Rhabdomyosarcoma
Study Phase
Phase 3
Study Completion Date
December 2014
NCT00354835Uploaded 10-06-2020
Access via NCI by Request
PDS UID: nci-data-431
Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)
Provider Information
Provider Data DescriptionThere 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.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset0
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNA
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, 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 combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.
ConditionsAdult Malignant Mesenchymoma
Adult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Childhood Malignant Mesenchymoma
Non-Metastatic Childhood Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Untreated Childhood Rhabdomyosarcoma
Intervention TypeDrug: Irinotecan Hydrochloride
Biological: Dactinomycin
Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Radiation: Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Drug(s)Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Drug: Irinotecan Hydrochloride
Total Enrolled481
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionVAC - Active Comparator
VAC Alternating with VI - Experimental
Secondary IDNCI-2009-00427
PubMed (PMID)31174239
30091945
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age RangeMinimum Age: NA
Maximum Age: 49 Years
Files: NCT00354835-D1
Data DictionaryNCT00354835-D1-Data-Dictionary_3.pdf
DATANCT00354835-D1-Dataset_3.csv
OTHERREADME.pdf
Files: NCT00354835-D2
Data DictionaryNCT00354835-D2-Data-Dictionary_4.pdf
DATANCT00354835-D2-Dataset_3.csv
OTHERREADME.pdf
Files: NCT00354835-D3
Data DictionaryNCT00354835-D3-Data-Dictionary_4.pdf
DATANCT00354835-D3-Dataset_2.csv
OTHERREADME.pdf
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