Low Risk Differentiated Thyroid Cancer Clinical Trial
— ESTIMABL2Official title:
Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
| Verified date | May 2023 |
| Source | Gustave Roussy, Cancer Campus, Grand Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group). The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)
| Status | Active, not recruiting |
| Enrollment | 776 |
| Est. completion date | January 1, 2030 |
| Est. primary completion date | April 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Patients with differentiated thyroid cancer (papillary, follicular or with Hurthle cells) in the absence of aggressive histological subtypes (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing or with an anaplastic component) 2. Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection 3. Total thyroidectomy performed 2 to 5 months before inclusion 4. Patients with low risk of recurrence: pT1amN0 or pT1amNx with a sum of the size of the lesions above 1 cm and equal to or less than 2 cm, or pT1bN0 or pT1bNx (TNM 2010 classification). 5. Post-operative neck ultrasound (performed 2 to 5 months after surgery) showing the absence of abnormalities in the lateral lymph node compartments, or if abnormalities, no lymph nodes with abnormal cytology and/or thyroglobulin concentration in the aspirate fluid > 10 ng/mL 6. Age >=18 years 7. Performance status of 0 or 1 8. Patients who signed the informed consent 9. Patients who can be followed-up annually during 5 years in order to assess the objectives of the study 10. Women of childbearing age should have a negative pregnancy test before any radioiodine administration 11. Both patients with or without thyroglobulin antibodies are eligible Exclusion Criteria: 1. Patients having undergone less than a total thyroidectomy 2. Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component) 3. Patients having undergone total thyroidectomy less than 2 months or more than 5 months before inclusion 4. Patients with cancer classified as pT1a unifocal (in which ablation is not necessary), or pT1N1, pT2, pT3, pT4 or N1 (who have a higher risk of recurrence) (classification TNM 2010) 5. Patient with known distant metastasis 6. Abnormal post-operative neck ultrasound of the lateral lymph node compartments 7. Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer) 8. Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks. 9. Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine 10. Pregnant or breast feeding women 11. Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Gustave Roussy | Villejuif | Val De Marne |
| Lead Sponsor | Collaborator |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patient without event at 3 years following randomization | assessed up to 3 years | ||
| Secondary | Lachrymal and Salivary Glands Toxicities | Assessed up at baseline, 2 months, 10 months and 3 years after randomization | ||
| Secondary | Patient's quality of life, anxiety and fear of recurrence | at inclusion, 2 months after inclusion, 10 months and 3 years after randomization | ||
| Secondary | Rate of patients without event | at 5 years following randomization | ||
| Secondary | Rate of events adjusted on the initial lymph node status | at 3 and 5 years following randomization | ||
| Secondary | Recurrence rate (histologically proven) | at 3 years following randomization and then at 5 years | ||
| Secondary | Rate of cure after an event | at 5 years after randomization | ||
| Secondary | Cost of treatment and follow-up | at 3 years after randomization | ||
| Secondary | Rate of events adjusted on tumoral molecular characterization | 3 and 5 years after randomization |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05510934 -
Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
|