Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Conditions
Low Risk Differentiated Thyroid Cancer
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: rhTSH stimulation Type: Drug
Name: I131 Type: Drug
Name: Follow up Type: Other
Overall Status
Recruiting
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)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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. Surgery performed 2 to 4 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). (Patients with less than 6 lymph nodes in the neck dissection will be classified as Nx)

5. Post-operative neck ultrasound (performed 2 to 4 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 surgery less than 2 months or more than 4 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
Location
Institut Gustave Roussy
Villejuif, Val de Marne, France
Status: Recruiting
Contact: Sophie LEBOULLEUX, MD - 0142114257 - sophie.leboulleux@igr.fr
Start Date
April 2013
Completion Date
October 2020
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Source
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page