Clinical trial NCT03416686: Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
Official title: Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Differentiated Thyroid Cancer
Keywords: differentiated thyroid cancer
Radiofrequency
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiofrequency with local anesthesia: 1 episode of treatment
Primary purpose: TREATMENT

Brief summary: Radiofrequency (RF) could be technically feasible and effective in the treatment of lymph node metastases of differentiated thyroid cancer. It could constitute a minimally invasive and feasible therapeutic alternative in ambulatory, allowing a reduction of the tumoral volume sufficient to limit the symptoms even to induce a tumor remission, a normalization of the tumoral markers and a better quality of life.

The aim of this study is to evaluate the anti-tumor echographic efficacy at 12 months of radiofrequency on lymph node (LN) metastasis of thyroid cancer


Eligibility criteria: Inclusion Criteria:

* Patients over age of 18 years
* with differentiated thyroid cancer (papillary, follicular) histologically confirmed, and absence of anaplastic component
* Previous treatment by total thyroidectomy and cervical lymph node dissection.
* Previous treatment by at least 1 therapeutic radioactive iodine (minimum activity 740MBq)
* Persistence on cervical ultrasound of at least 1 cervical metastatic lymph node, visible at ultrasound, small diameter between ≥10 mm and ≤30mm, volume maximum 20ml, spotted on a picture, and confirmed by cyto-punction
* Signed informed consent

Exclusion Criteria:

* Location of LN metastasis with significant risk of local complication (nervous, vascular) according baseline ultrasound assessment
* Patient carrier of a pacemaker or a defibrillator
* Congenital or acquired hemostasis abnormality, anticoagulant therapy or double platelet antiaggregatory (aspirin and clopidogrel)
* Hypersensitivity to local anesthetic
* Poor general condition (performance status Eastern Cooperative Oncology Group (ECOG) \> 1)
* Survival estimated less than 12 months
* Patient who can't follow the instructions of RF therapy or who can't be followed during 2 years in order to meet the objectives of the study
* Non affiliation to a social security
* Pregnant or breast feeding women at the time of RF
* Beta hormone chorionic gonadotrope (HCG) positive test (pregnancy) before RF therapy
* Baseline cervical ultrasound, by expert operator trained to RF, not fulfilling feasibility criteria for RF realisation because of the location of LN metastasis or the way to reach it
* Controlateral recurrent palsy on nasofibroscopy

Primary outcomes:
measure: Treatment response.
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF
timeFrame: 6 months
measure: Percentage of patients without any new suspicious cervical lesion
timeFrame: 3, 6, 12 and 24 months.
measure: Response time
timeFrame: within 38 months
measure: Reduction in thyroglobulin level in blood
timeFrame: 3, 6, 12 and 24 months
measure: Reduction in thyroglobulin antibody level in blood
timeFrame: 3, 6, 12 and 24 months
measure: Percentage of patient in tumor response
timeFrame: 12 and 24 months
measure: Percentage of patients without any new therapeutic event
timeFrame: 12 and 24 months
measure: Percentage of patients with good immediate tolerance
timeFrame: day 0
measure: Percentage of (either expected or unexpected) clinical complications
timeFrame: 3, 6, 12 and 24 months
measure: Percentage of patients who had a RF complete procedure
timeFrame: day 0
measure: Percentage of patients who had a RF incomplete procedure
timeFrame: day 0
measure: Anxiety
timeFrame: 3, 6, 12 and 24 months
measure: 36-item Medical Outcomes Study Short-Form Health Survey (SF-36)
timeFrame: 3, 6, 12 and 24 months
measure: EuroQol (EQ-5D)
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Louis
Study officials:
References: