NCT01837745Active, not recruitingPhase 3
Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Source: ClinicalTrials.gov · Last updated 17 May 2023
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 776 (actual)
- First submitted
- 16 Apr 2013
- Start date
- 13 May 2013
- Primary completion date
- 1 Apr 2022
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Diseases
- Thyroid cancer
- NCT number
- NCT01837745
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 776
- From 13 May 2013 to the primary completion date, 1 Apr 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients having undergone total thyroidectomy less than 2 months or more than 5 months before inclusion
- Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine
Other illness
- 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)
- 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.
- Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures
Other
- 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)
- Patient with known distant metastasis
- Abnormal post-operative neck ultrasound of the lateral lymph node compartments
- Pregnant or breast feeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.