An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors

Brief Summary

The purpose of the study was 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.

Brief Title

Detailed Description

The primary objective of this study was 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.

Categories

Endocrine System Cancers

Cancer

Diabetes

Diabetes & Endocrine System

Completion Date

2020-07-24

Completion Date Type

Actual

Conditions

Thyroid Neoplasms

Eligibility 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 Response Evaluation Criteria in Solid Tumors (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

Inclusion 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* No symptoms due to DTC
* \>/=1cm diameter of lesion confirmed by radiological exam
* Life expectancy of at least 6 months

Gender

All

Gender Based

false

Keywords

Progressive radioactive iodine refractory differentiated thyroid carcinoma

Healthy Volunteers

No

Last Update Post Date

Thu, 06/08/2023 - 12:00

Last Update Post Date Type

Actual

Last Update Submit Date

Wed, 06/07/2023 - 12:00

Minimum Age

18 Years

NCT Id

NCT02303444

Org Class

Industry

Org Full Name

Bayer

Org Study Id

17852

Overall Status

Completed

Primary Completion Date

Wed, 06/10/2020 - 12:00

Primary Completion Date Type

Actual

Official Title

RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors

Primary Outcomes

Outcome Description

TTSP is defined as the time interval from the day of study entry to the date of first symptomatic progression. Patients who do not have a symptomatic progression at the time of analysis will be censored at the date of their last evaluable assessment.

Outcome Measure

Time to symptomatic progression (TTSP) from study entry

Outcome Time Frame

Up to 6 years

Secondary Ids

Secondary Id

NX1401

Secondary Outcomes

Outcome Description

Defined as the time interval from the date of study entry to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.

Outcome Time Frame

Up to 6 years

Outcome Measure

Overall survival (OS) from time of study entry

Outcome Description

Defined as the time interval from the date of study entry to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.

Outcome Time Frame

Up to 6 years

Outcome Measure

Progression free survival (PFS) from time of study entry

Outcome Description

Defined as the time interval from the day of being diagnosed as RAI refractory to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.

Outcome Time Frame

Up to 6 years

Outcome Measure

OS from time of being diagnosed as radioactive iodine (RAI) refractory

Outcome Description

Defined as the time interval from the date of symptomatic progression to death due to any cause. Patients without symptomatic progression will be excluded from analysis and patients who are alive at the time of analysis will be censored at the last date when they were known to be alive.

Outcome Time Frame

Up to 6 years

Outcome Measure

Post-progression survival (PPS) from time of symptomatic progression

Outcome Description

Defined as the time interval from the day of start of the first MKI to death due to any cause. Patients alive at the time of analysis will be censored at the last date when they were known to be alive.

Outcome Time Frame

Up to 6 years

Outcome Measure

OS from initiation of the first Multikinase Inhibitor (MKI)

Outcome Description

Defined as the time interval from the day of start of first MKI to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.

Outcome Time Frame

Up to 6 years

Outcome Measure

PFS from initiation of first MKI

Outcome Description

Defined as the time interval from the date of start of any systemic treatment regimen to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.

Outcome Time Frame

Up to 6 years

Outcome Measure

OS from initiation of any systemic treatment regimen

Outcome Description

Defined as the time interval from the date of start of any systemic treatment regimen to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.

Outcome Time Frame

Up to 6 years

Outcome Measure

PFS from initiation of any systemic treatment regimen

Outcome Description

Defined as the time interval from the day of start of a treatment to the date of permanent discontinuation of a treatment (regardless of the reason for discontinuation including death). It includes interruption or drug holiday.

Outcome Time Frame

Up to 6 years

Outcome Measure

Duration of each systemic treatment regimen

Outcome Description

In case of "Clinical Progression" the CRF will ask for the presence of specific symptoms.

Outcome Time Frame

Up to 6 years

Outcome Measure

Response assessment to each systemic treatment regimen according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression", and "Not evaluable at this visit"

Outcome Description

Defined as the time interval from the day of start of sorafenib to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.

Outcome Time Frame

Up to 6 years

Outcome Measure

OS from initiation of sorafenib

Outcome Description

Defined as the time interval from the date of start of sorafenib to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.

Outcome Time Frame

Up to 6 years

Outcome Measure

PFS from initiation of sorafenib

Outcome Time Frame

Up to 6 years

Outcome Measure

Daily dose of sorafenib per patient throughout the treatment period

Outcome Time Frame

Up to 6 years

Outcome Measure

Number of adverse events during treatment with sorafenib