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Type(s) of Cancer
Desmoid Fibromatosis
Study Phase
Phase 3
Study Completion Date
2019-07-03
NCT02066181Uploaded 04-14-2021
Access via NCI by Request
PDS UID: nci-data-465
A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)
Provider Information
Provider Data DescriptionDataset NCT02066181-D1-Dataset.csv (consort) is one of 6 datasets associated with PubMed ID 30575484. This dataset contains information concerning the consort diagram.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. \[Funding Source - FDA OOPD\]
ConditionsDesmoid Fibromatosis
Intervention TypeOther: Laboratory Biomarker Analysis
Other: Placebo Administration
Other: Quality-of-Life Assessment
Drug: Sorafenib Tosylate
Drug(s)Drug: Sorafenib Tosylate
Total Enrolled87
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (sorafenib tosylate) - Experimental
Arm II (placebo) - Placebo Comparator
Secondary IDNCI-2014-00264
PubMed (PMID)34420143
33258687
30575484
Collaborator(s)N/A
Region(s)United States
Canada
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT02066181-D1
Data DictionaryNCT02066181-D1-Data-Dictionary_0.pdf
DATANCT02066181-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02066181-D2
Data DictionaryNCT02066181-D2-Data-Dictionary_0.pdf
DATANCT02066181-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02066181-D3
Data DictionaryNCT02066181-D3-Data-Dictionary_0.pdf
DATANCT02066181-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02066181-D4
Data DictionaryNCT02066181-D4-Data-Dictionary_0.pdf
DATANCT02066181-D4-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02066181-D5
Data DictionaryNCT02066181-D5-Data-Dictionary_0.pdf
DATANCT02066181-D5-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02066181-D6
Data DictionaryNCT02066181-D6-Data-Dictionary_0.pdf
DATANCT02066181-D6-Dataset_0.csv
OTHERREADME.pdf
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