Status:
ACTIVE_NOT_RECRUITING
Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Low Risk Differentiated Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 m...
Eligibility Criteria
Inclusion
- 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).
- 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
- 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 total thyroidectomy less than 2 months or more than 5 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
Key Trial Info
Start Date :
May 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2030
Estimated Enrollment :
776 Patients enrolled
Trial Details
Trial ID
NCT01837745
Start Date
May 13 2013
End Date
January 1 2030
Last Update
May 17 2023
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, Val De Marne, France, 94805