Differentiated Thyroid Cancer
Conditions
Keywords
differentiated thyroid cancer, Radiofrequency
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
Interventions
DEVICERadiofrequency (RF star electrode electrode_Fixed)
The radiofrequency will be performed under ultrasound control after local anesthesia by a trained operator, after finding the lesion to be treated by the operator. Medical device used: RF star electrode electrode\_Fixed (Starmed Co,Gyeonggi-do, Korea, French representative Cosysmed).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Radiofrequency with local anesthesia: 1 episode of treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response. | 12 months | Treatment success wil; be defined on the following three criteria that should be all fulfilled * Loss of metastatic aspect on ultrasonography * LN decreased volume at least 50% * no vascularization in Doppler |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF | 6 months | — |
| Percentage of patients without any new suspicious cervical lesion | 3, 6, 12 and 24 months. | — |
| Response time | within 38 months | response time for partial response, major response and disappearance of lymph node at ultrasound. |
| Reduction in thyroglobulin level in blood | 3, 6, 12 and 24 months | — |
| Reduction in thyroglobulin antibody level in blood | 3, 6, 12 and 24 months | — |
| Percentage of patient in tumor response | 12 and 24 months | Tumor response is defined according American Thyroid Association's criteria |
| Percentage of patients without any new therapeutic event | 12 and 24 months | — |
| Percentage of patients with good immediate tolerance | day 0 | — |
| Percentage of (either expected or unexpected) clinical complications | 3, 6, 12 and 24 months | — |
| Percentage of patients who had a RF complete procedure | day 0 | — |
| Percentage of patients who had a RF incomplete procedure | day 0 | — |
| Anxiety | 3, 6, 12 and 24 months | visual analog scale coted by the patient |
| 36-item Medical Outcomes Study Short-Form Health Survey (SF-36) | 3, 6, 12 and 24 months | it measures the quality of life |
| EuroQol (EQ-5D) | 3, 6, 12 and 24 months | EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
Countries
France
Outcome results
None listed