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Completed

NCT Number: NCT02303444

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

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.

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Algeria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Patients can get sorafenib at any time during study.

Other Multikinase inhibitors

Drug

Patients can get MKIs at any time during study.

Primary outcomes

  1. Time to symptomatic progression (TTSP) from study entry

    Time frame: Up to 6 years

    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.

Secondary outcomes

  1. Overall survival (OS) from time of study entry

    Time frame: Up to 6 years

    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.

  2. Progression free survival (PFS) from time of study entry

    Time frame: Up to 6 years

    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.

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

    Time frame: Up to 6 years

    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.

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

    Time frame: Up to 6 years

    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.

  5. OS from initiation of the first Multikinase Inhibitor (MKI)

    Time frame: Up to 6 years

    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.

  6. PFS from initiation of first MKI

    Time frame: Up to 6 years

    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.

  7. OS from initiation of any systemic treatment regimen

    Time frame: Up to 6 years

    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.

  8. PFS from initiation of any systemic treatment regimen

    Time frame: Up to 6 years

    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.

  9. Duration of each systemic treatment regimen

    Time frame: Up to 6 years

    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.

  10. 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"

    Time frame: Up to 6 years

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

  11. OS from initiation of sorafenib

    Time frame: Up to 6 years

    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.

  12. PFS from initiation of sorafenib

    Time frame: Up to 6 years

    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.

  13. Daily dose of sorafenib per patient throughout the treatment period

    Time frame: Up to 6 years

  14. Number of adverse events during treatment with sorafenib

    Time frame: Up to 6 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: RIFTOS MKI

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2014
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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