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Type(s) of Cancer
CNS
Study Phase
Phase 3
Study Completion Date
2015-12-31
NCT00304070Uploaded 02-27-2024
Access via NCI by Request
PDS UID: nci-data-537
Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study
Provider Information
Provider Data DescriptionNCT00304070-D1: There are 2 datasets associated with the PMID 33822640: NCT00304070-D1 and NCT00304070-D2. This dataset, NCT00304070-D1, provides the information for baseline characteristics and all analyses reported in the manuscript (consort diagram, Tables 1 to 5, Figures 1 & 2, and Appendix Table A2). There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
ConditionsStage I Adrenal Cortical Carcinoma AJCC v7
Stage II Adrenal Cortical Carcinoma AJCC v7
Stage III Adrenal Cortical Carcinoma AJCC v7
Stage IV Adrenal Cortical Carcinoma AJCC v7
Intervention TypeDrug: Cisplatin
Procedure: Conventional Surgery
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Biological: Filgrastim
Drug: Mitotane
Biological: Pegfilgrastim
Drug(s)Drug: Cisplatin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Mitotane
Total Enrolled78
RandomizationNon Randomized
Blinding MethodNone
Arms InterventionStratum I (surgery, observation) - Experimental
Stratum II (exploratory surgery, observation) - Experimental
Stratum III (chemotherapy, surgery) - Experimental
Secondary IDNCI-2009-00413
PubMed (PMID)34675114
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Brazil
Canada
Age Range21 Years and younger (CHILD, ADULT)
Files: NCT00304070-D1
Data DictionaryNCT00304070-D1-Data-Dictionary_2.pdf
DATANCT00304070-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00304070-D2
Data DictionaryNCT00304070-D2-Data-Dictionary_2.pdf
DATANCT00304070-D2-Dataset_0.csv
OTHERREADME.pdf
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