Clinical trial NCT01837745: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Official title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Low Risk Differentiated Thyroid Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patient without event at 3 years following randomization
timeFrame: assessed up to 3 years
Secondary outcomes:
measure: Lachrymal and Salivary Glands Toxicities
timeFrame: Assessed up at baseline, 2 months, 10 months and 3 years after randomization
measure: Patient's quality of life, anxiety and fear of recurrence
timeFrame: at inclusion, 2 months after inclusion, 10 months and 3 years after randomization
measure: Rate of patients without event
timeFrame: at 5 years following randomization
measure: Rate of events adjusted on the initial lymph node status
timeFrame: at 3 and 5 years following randomization
measure: Recurrence rate (histologically proven)
timeFrame: at 3 years following randomization and then at 5 years
measure: Rate of cure after an event
timeFrame: at 5 years after randomization
measure: Cost of treatment and follow-up
timeFrame: at 3 years after randomization
measure: Rate of events adjusted on tumoral molecular characterization
timeFrame: 3 and 5 years after randomization
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val De Marne
Study officials:
References:
citation: Leboulleux S, Bournaud C, Chougnet CN, Zerdoud S, Al Ghuzlan A, Catargi B, Do Cao C, Kelly A, Barge ML, Lacroix L, Dygai I, Vera P, Rusu D, Schneegans O, Benisvy D, Klein M, Roux J, Eberle MC, Bastie D, Nascimento C, Giraudet AL, Le Moullec N, Bardet S, Drui D, Roudaut N, Godbert Y, Morel O, Drutel A, Lamartina L, Schvartz C, Velayoudom FL, Schlumberger MJ, Leenhardt L, Borget I. Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer. N Engl J Med. 2022 Mar 10;386(10):923-932. doi: 10.1056/NEJMoa2111953.