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Type(s) of Cancer
Uterine
Study Phase
Phase 3
Study Completion Date
2018-06-30
NCT01533207Uploaded 02-12-2020
Access via NCI by Request
PDS UID: nci-data-405
A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin and Observation from PubMed 30289732.
SponsorGynecologic Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.
ConditionsStage I Uterine Sarcoma AJCC v7
Uterine Corpus Leiomyosarcoma
Intervention TypeOther: Clinical Observation
Drug: Docetaxel
Drug: Doxorubicin Hydrochloride
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Drug(s)Drug: Docetaxel
Drug: Doxorubicin Hydrochloride
Drug: Gemcitabine Hydrochloride
Total Enrolled38
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (chemotherapy) - Experimental
Arm II (no treatment) - Other
Secondary IDNCI-2012-00249
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Belgium
France
Netherlands
Norway
Spain
United Kingdom
Venezuela
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01533207-D1
Data DictionaryNCT01533207-D1-Data-Dictionary_1.pdf
DATANCT01533207-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01533207-D2
Data DictionaryNCT01533207-D2-Data-Dictionary_2.pdf
DATANCT01533207-D2-Dataset_1.csv
OTHERREADME.pdf
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