Papillary thyroid carcinoma Thyroid cancer
Conditions
Interventions
Patients diagnosed with PTC on FNA prior to surgery are randomized between the
interventional treatment (HTx+AS) and regular care (TTx+RAI).
The investigational treatment is thus a hemi-thyroidectom
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Able to undergo surgery - Age of 18 years and older - Diagnosed with unilateral papillary thyroid cancer with a diameter of 1-4 cm, as defined by: o Histologically proven well differentiated (classic or follicular variant) PTC after diagnostic hemithyroidectomy 1-4cm or o Cytologically proven Bethesda 6 or o Cytologically proven Bethesda 5 nodule with confirmed BRAF mutation - Size of index nodule / tumor must be between 1 and 4cm, measured by ultrasound or on histopathology. Histopathology may overrule ultrasound measurements. - Ultrasound of the neck excluding lymph node involvement - Signed informed consent by patient
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Positive resection margins or extensive extrathyroidal extension as defined for in the 8th edition of the AJCC/TNM classification of thyroid cancer for extension of a T3 tumor upon histology or ultrasound. - Lymph node involvement confirmed by ultrasound and FNA prior to randomization - Multifocality - Vascular invasion - Aggressive histology (e.g. poorly differentiated, tall cell, columnar cell, hobnail variant, diffuse sclerosing variant PTC) - Certain classification of NIFTP on histology - A contralateral nodule requiring intervention (if applicable) - Pregnant women - Insufficient understanding of the Dutch language to understand the study documents - Minors (age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study outcome Primary endpoint consists of the participation of patients eligible for the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Time needed to include 12 patients 2. Reasons for patients to deny participation 3. Total number of patients and percentage of patients in the active surveillance group who wish to be treated according to the current guidelines 4. Quality of life outcomes as assessed by EQ5D5L, SF-36, ThyPro39 and the Fear of Cancer Recurrence questionnaires. 5. Logistical hurdles | — |
Countries
Netherlands
Outcome results
None listed