Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

  • STATUS
    Recruiting
  • End date
    Apr 21, 2022
  • participants needed
    780
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 21 January 2021

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)

Details
Condition Low Risk Differentiated Thyroid Cancer
Treatment Follow Up, rhTSH stimulation, I131
Clinical Study IdentifierNCT01837745
SponsorGustave Roussy, Cancer Campus, Grand Paris
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Low Risk Differentiated Thyroid Cancer?
Do you have any of these conditions: Do you have Low Risk Differentiated Thyroid Cancer??
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)
Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection
Total thyroidectomy performed 2 to 5 months before inclusion
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). (Patients with less than 6 lymph nodes in the neck dissection will be classified as Nx)
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
Age >=18 years
Performance status of 0 or 1
Patients who signed the informed consent
Patients who can be followed-up annually during 5 years in order to assess the objectives of the study
Women of childbearing age should have a negative pregnancy test before any radioiodine administration
Both patients with or without thyroglobulin antibodies are eligible

Exclusion Criteria

Patients having undergone less than a total thyroidectomy
Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component)
Patients having undergone surgery less than 2 months or more than 4 months before inclusion
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)
Patient with known distant metastasis
Abnormal post-operative neck ultrasound of the lateral lymph node compartments
Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer)
Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks
Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine
Pregnant or breast feeding women
Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures
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