Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02084732
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2014-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study
Sponsor:
Instituto Nacional de Cancerologia, Columbia
Organization:
Study Overview
Official Title:
Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010).
Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system.
The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.
Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells.
VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival.
Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies.
Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms.
Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.
Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system.
The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.
Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells.
VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival.
Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies.
Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms.
Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.
Detailed Description:
Objective:
Determine the clinical efficacy and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) in a 24 months follow up period.
Analysis plan The analysis plan includes the description of clinical and epidemiological characteristics of recruited patients at the end of the first year and the before and after comparison from clinical response according to RECIST criteria. At the end of the first and second follow-up years, analyses will be performed. In each of these, the response of patients by outcomes of interest measured at specific monitoring times will be evaluated.
Parametric and non-parametric descriptive statistics will be used as necessary; the comparison of some variables between baseline measurements and follow-up predetermined cut-offs will be performed while taking into account the lack of independence between observations. Analysis of qualitative variables will be performed using McNemar's Test and the analysis of quantitative variables using the Paired Student's t-Test or Wilcoxon Test depending on the normality of the distribution
Descriptive statistics will be used for time until events, survival curve and progression-free time median will be stated. Correlation studies between some indicators, clinical variables, and observed outcomes using parametric and non-parametric coefficients will be performed. Interobserver agreement will be evaluated for the reading of diagnostic images using a Kappa coefficient.
Determine the clinical efficacy and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) in a 24 months follow up period.
Analysis plan The analysis plan includes the description of clinical and epidemiological characteristics of recruited patients at the end of the first year and the before and after comparison from clinical response according to RECIST criteria. At the end of the first and second follow-up years, analyses will be performed. In each of these, the response of patients by outcomes of interest measured at specific monitoring times will be evaluated.
Parametric and non-parametric descriptive statistics will be used as necessary; the comparison of some variables between baseline measurements and follow-up predetermined cut-offs will be performed while taking into account the lack of independence between observations. Analysis of qualitative variables will be performed using McNemar's Test and the analysis of quantitative variables using the Paired Student's t-Test or Wilcoxon Test depending on the normality of the distribution
Descriptive statistics will be used for time until events, survival curve and progression-free time median will be stated. Correlation studies between some indicators, clinical variables, and observed outcomes using parametric and non-parametric coefficients will be performed. Interobserver agreement will be evaluated for the reading of diagnostic images using a Kappa coefficient.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: