Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer

Titre officiel

Active Surveillance or Surgery for Primary Management of Very Low Risk Papillary Thyroid Cancer: How Often Are the Long-term Disease Management Goals Achieved?

Sommaire:

Il s’agit d’une étude prospective, observationnelle et multicentrique examinant les résultats à long terme de patients atteints d’un cancer papillaire de la thyroïde de petite taille et à faible risque, qui ont eu le choix entre une surveillance active (suivi étroit pour surveiller la progression potentielle de la maladie) ou une intervention chirurgicale immédiate.

Description de l'essai

Primary Outcome:

• Number of Participants in the Active Surveillance Group who Experience 'Failure' of Active Surveillance Disease Management
• Number of Participants in the Surgical Group who Experience 'Failure' of Surgical Disease Management

Secondary Outcome:

• Number of Participants in Respective Thyroid Cancer Disease Status Categories at Last Follow-up
• Number of Participants in the Active Surveillance Group who Undergo Thyroidectomy During Follow-up
• Number of Participants who Experience Long-term Complications of Thyroid Surgery
• Description of Quality of Life (Thyroid Cancer-specific)
• Description of Quality of Life (Cancer-specific)
• Measure of Anxiety
• Measure of Survivor Concerns
• Measure of Decision Regret (relating to the original decision to undergo active surveillance or thyroid surgery).

This is a prospective, observational multi-centre study, building on an initial single-centre study from Toronto, Canada (ClinicalTrials.gov Identifier: NCT03271892). Adult patients with small, low-risk papillary thyroid cancer may choose either active surveillance (close follow-up with the intention of surgery if the disease progresses or if the patient changes their mind and wants surgery) or immediate thyroid surgery (thyroidectomy). Patients who choose active surveillance are clinically followed at the participating study centre and those who choose surgery, receive usual care from their treating surgeon and/or other thyroid cancer specialists. Thyroid cancer clinical and treatment outcomes are tracked (by medical record review) at least yearly for up to 10 years after enrollment. Patients are also asked to complete study questionnaires (patient reported outcomes) yearly for up to 5 years. The underlying assumption in the study is that since patients' disease management goals differ for individuals choosing active surveillance and those choosing surgery, 'successful' disease management is defined differently for these patient groups. For patients choosing active surveillance, successful disease management may be defined by avoiding thyroid surgery for thyroid cancer progression (i.e. thyroid cancer that has grown or spread to other tissues). For patients choosing surgery, the ultimate goal is cure of the thyroid cancer (i.e. no thyroid cancer detected at long-term follow-up). The primary analysis in this study is a description of how often patients' initial disease management goals are not achieved at long-term follow-up. For this study, 'failure' of disease management is defined as follows: a) in active surveillance group

• surgery for disease progression, and b) in the immediate surgery group

• requiring additional treatment for persistent or recurrent thyroid cancer (i.e. thyroid cancer that is detected and treated in follow-up). Thyroid cancer clinical and treatment outcomes as well as patient questionnaire outcomes will be reported.

Voir cet essai sur ClinicalTrials.gov