NCTN: Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) (CALGB-80802)
Study ID: CALGB-80802
NCT Number: NCT01015833
Alliance for Clinical Trials in Oncology
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: Phase III Randomized Study of Sorafenib plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) (CALGB-80802)
Trial Description: This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with liver cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
Data presented in the following publication(s):
- PMID 31486832
Disease type(s): Gastrointestinal Neoplasm - Liver and Hepatobiliary Cancer
Clinical Dataset(s) included:
- NCT01015833-D1 (PMID 31486832): Dataset NCT01015833-D1 is the only dataset associated with PubMed ID 31486832. This dataset contains baseline characteristics, treatment arm and number of cycles, treatment discontinuation reasons, hepatitis status, toxicity, and survival data.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)