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Type(s) of Cancer
Gestational Trophoblastic Tumor
Study Phase
Phase 3
Study Completion Date
2018-05-31
NCT01535053Uploaded 04-20-2024
Access via NCI by Request
PDS UID: nci-data-541
A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia
Provider Information
Provider Data DescriptionThere are two submissions associated with PMID 34260997. This dataset, NCT01535053-D1, contains treatment comparison data between Actinomycin-D and Methotrexate in trial NCT01535053.
SponsorGOG Foundation
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, 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 methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.
ConditionsChoriocarcinoma
FIGO Stage I Gestational Trophoblastic Tumor
FIGO Stage II Gestational Trophoblastic Tumor
FIGO Stage III Gestational Trophoblastic Tumor
Hydatidiform Mole
Intervention TypeBiological: Dactinomycin
Drug: Leucovorin Calcium
Drug: Methotrexate
Other: Quality-of-Life Assessment
Drug(s)Drug: Leucovorin Calcium
Drug: Methotrexate
Total Enrolled57
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (dactinomcin) - Experimental
Arm II (leucovorin calcium and methotrexate) - Active Comparator
Secondary IDNCI-2012-00250
PubMed (PMID)32460997
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Japan
Korea, Republic of
United Kingdom
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01535053-D1
Data DictionaryNCT01535053-D1-Data-Dictionary_2.pdf
DATANCT01535053-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01535053-D2
Data DictionaryNCT01535053-D2-Data-Dictionary_2.pdf
DATANCT01535053-D2-Dataset_2.csv
OTHERREADME.pdf
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