An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors
Conditions
Thyroid Neoplasms
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Progressive radioactive iodine refractory differentiated thyroid carcinoma
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Sorafenib (Nexavar, BAY43-9006) Type: Drug
Name: Other Multikinase inhibitors Type: Drug
Overall Status
Recruiting
Summary
The purpose of the study is to assess the use of Multikinase Inhibitors (MKIs) in the treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) who do not have any symptoms.
Detailed Description
The primary objective of this study is to compare time to symptomatic progression (TTSP) from study entry in asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry with that of asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically/cytologically documented DTC (papillary, follicular, Hurthle cell, and poorly differentiated carcinoma)

- DTC refractory to RAI

- Radiological progression and preferably according to RECIST 1.1

- No symptoms due to DTC

- >/=1cm diameter of lesion confirmed by radiological exam

- Life expectancy of at least 6 months

Exclusion Criteria:

- Plan to be treated according to a clinical trial protocol for intervention including a locoregional therapy or systemic therapy

- Previous treatment with MKIs for advanced disease

- Hospice patients
Locations
Boston, Massachusetts, United States
Status: Not yet recruiting
Philadelphia, Pennsylvania, United States
Status: Recruiting
Many locations, Algeria
Status: Not yet recruiting
Many locations, Argentina
Status: Not yet recruiting
Many locations, Austria
Status: Terminated
Many locations, Brazil
Status: Not yet recruiting
Many locations, Denmark
Status: Terminated
Many locations, Egypt
Status: Not yet recruiting
Many locations, France
Status: Not yet recruiting
Many Locations, Germany
Status: Not yet recruiting
Many locations, Greece
Status: Not yet recruiting
Many locations, India
Status: Not yet recruiting
Many locations, Indonesia
Status: Not yet recruiting
Many locations, Israel
Status: Not yet recruiting
Many locations, Japan
Status: Recruiting
Many locations, Lebanon
Status: Not yet recruiting
Many locations, Mexico
Status: Not yet recruiting
Many locations, Netherlands
Status: Not yet recruiting
Many locations, Norway
Status: Terminated
Many locations, Philippines
Status: Not yet recruiting
Many locations, Russian Federation
Status: Not yet recruiting
Many locations, Saudi Arabia
Status: Not yet recruiting
Many locations, Spain
Status: Not yet recruiting
Many locations, Sweden
Status: Terminated
Many locations, Taiwan
Status: Not yet recruiting
Many locations, Turkey
Status: Not yet recruiting
Many locations, United Arab Emirates
Status: Not yet recruiting
Start Date
April 2015
Completion Date
March 2019
Sponsors
Bayer
Source
Bayer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page