Low Risk Differentiated Thyroid Cancer
Conditions
Brief summary
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)
Interventions
DRUGrhTSH stimulation
Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
DRUGI131
An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.
OTHERFollow up
* 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation * 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4) * 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 4 years (+/- 2 months) after randomization: a serum Tg/LT4 * 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patient without event at 3 years following randomization | assessed up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Patient's quality of life, anxiety and fear of recurrence | at inclusion, 2 months after inclusion, 10 months and 3 years after randomization |
| Rate of patients without event | at 5 years following randomization |
| Rate of events adjusted on the initial lymph node status | at 3 and 5 years following randomization |
| Lachrymal and Salivary Glands Toxicities | Assessed up at baseline, 2 months, 10 months and 3 years after randomization |
| Rate of cure after an event | at 5 years after randomization |
| Cost of treatment and follow-up | at 3 years after randomization |
| Rate of events adjusted on tumoral molecular characterization | 3 and 5 years after randomization |
| Recurrence rate (histologically proven) | at 3 years following randomization and then at 5 years |
Countries
France
Outcome results
None listed