Trial record 18 of 379 for:    Open Studies | "Carcinoma, Hepatocellular"

Investigating Patient Characteristics of Intermediate Stage Hepatocellular Carcinoma Patients Treated With Nexavar and Their Distribution to Different Treatment Groups as Well as Determining Effectiveness and Safety (SORINT)

This study is currently recruiting participants.
Verified March 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01908322
First received: July 23, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.


Condition Intervention
Carcinoma, Hepatocellular
Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others). [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation). [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Further possible prognostic factors will be evaluated. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection. [ Time Frame: up to 54 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: August 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Patients will be followed-up from start of Nexavar therapy until death or drop out due to any reason or end of study

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of patients with intermediate stage hepatocellular carcinoma (BCLC-B) treated with Nexavar according to the local summary of product characteristics. Participants will be recruited from oncological and gastroenterological clinics and practices throughout Germany.

In this non-interventional observational study, the decision on the duration and dosage of treatment is solely at the discretion of the attending physician.

The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.

Criteria

Inclusion Criteria:

  • Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma (BCLC-B) for whom the decision has been taken by the investigator to prescribe Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients with large/multifocal HCC who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread).

Exclusion Criteria:

- Prior targeted therapy for hepatocellular carcinoma.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908322

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Germany
Recruiting
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01908322     History of Changes
Other Study ID Numbers: 16628
Study First Received: July 23, 2013
Last Updated: March 21, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Hepatocellular carcinoma
Intermediate stage
Observational study

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014