Primary Objective: The aim of this pilot study is to determine the willingness of patients to participate in a RCT regarding de-escalation of treatment of PTC and to observe adherence to this less aggressive approach. This will be accomplished by…
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Endocrine neoplasms malignant and unspecified
- Endocrine gland therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcome
Primary endpoint consists of the participation of patients eligible for the
study
Secondary outcome
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
Background summary
The worldwide incidence of papillary thyroid cancer (PTC) is increasing and
thyroid cancer is the most common endocrine malignancy worldwide. The incidence
rises due to increased use of imaging modalities such as ultrasonography, MRI
and PET/CT scan, which mainly leads to the identification of thyroid
incidentalomas, small well-differentiated papillary thyroid carcinomas. Despite
a shift towards a less aggressive treatment in the USA, described in the latest
American Thyroid Association guideline, the Dutch guidelines are more
aggressive in treating PTC. They recommend a total thyroidectomy (TTx) followed
by radioactive iodine (RAI) in all patients with a PTC >1 cm. This treatment
strategy comes with significant costs and morbidity rates caused by
hypothyroidism, iatrogenic hypo-parathyroidism, recurrent laryngeal nerve
damage, dysgeusia and xerostomia, resulting in a poor quality of life. The
stable overall survival rate suggests widespread overtreatment following
current treatment strategy. Therefore, changing treatment strategies for
low-risk PTC patients is of great importance. This is reflected by the 2015 ATA
guidelines stating that hemi thyroidectomy is sufficient for patients with
low-risk PTC based on large national USA registration database studies. These
studies show neither survival benefit nor difference in recurrence rate between
TTx versus hemi thyroidectomy (HTx) in this group of patients. Unfortunately,
the lack of strong evidence, such as randomized trials demonstrating equivalent
oncological outcomes is currently withholding widespread worldwide
de-escalation and is urgently required to update guidelines in non-American
countries. Prior to performing such a large-scale randomized controlled trial,
a pilot study is necessary to assess willingness to participate and adherence
to the active surveillance strategy. This pilot study will function as a
stepping stone to the aforementioned national RCT.
Study objective
Primary Objective:
The aim of this pilot study is to determine the willingness of patients to
participate in a RCT regarding de-escalation of treatment of PTC and to observe
adherence to this less aggressive approach. This will be accomplished by
measuring the participation rate of patients eligible and informed about the
study.
Study design
This is a single-center randomized controlled pilot study.
Intervention
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-thyroidectomy followed by active
surveillance.
Patients included after the diagnostic hemi thyroidectomy will be randomized
between the interventional treatment (AS) or regular care (completionTx+RAI).
Study burden and risks
There is a chance that a higher recurrence rate of PTC will be found in the
intervention group, which creates a greater burden due to re-operations.
However, this does not affect survival.
Potential reduced per/post-operative complications will benefit the
intervention group.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
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 < 18 years) and incapacitated subjects do not meet the
eligibility criteria and will therefore not be enrolled
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73675.078.20 |