Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients? (ESTIMABL2)

May 16, 2023 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
776

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Follow up group
Patients randomized in the follow up group neither received 131I nor rhTSH. Patients will undergo the same followup procedures as patients randomized to the ablation group, except that at 10 months after randomization, Tg will be measured under LT4 treatment and not after rhTSH stimulation.
Other: Follow up
  • 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation
  • 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4)
  • 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 4 years (+/- 2 months) after randomization: a serum Tg/LT4
  • 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
Active Comparator: Ablation group
  • Administration of 1.1 GBq of I131 is given after the second intramuscular injections of rhTSH (0.9 mg). A whole body scan (WBS) is performed 2 to 5 days after the administration or I131 with determination of the neck uptake.

  • Follow-up consists in:

    • 10 (+/- 2 months) after randomization: neck ultrasound + a serum Tg measurement after rhTSH stimulation
    • 2 years (+/- 2 months) after randomization: serum Tg measurement under LT4 treatment (Tg/LT4)
    • 3 years (+/- 2 months) after randomization: neck ultrasound and a serum Tg/LT4
    • 4 years (+/- 2 months) after randomization: a serum Tg/LT4
    • 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
    • 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
    • 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
    • 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
Drug: rhTSH stimulation
Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
Other Names:
  • Thyrogen
Drug: I131
An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.
Other: Follow up
  • 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation
  • 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4)
  • 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 4 years (+/- 2 months) after randomization: a serum Tg/LT4
  • 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  • 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of patient without event at 3 years following randomization
Time Frame: assessed up to 3 years
assessed up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Lachrymal and Salivary Glands Toxicities
Time Frame: Assessed up at baseline, 2 months, 10 months and 3 years after randomization
Assessed up at baseline, 2 months, 10 months and 3 years after randomization
Patient's quality of life, anxiety and fear of recurrence
Time Frame: at inclusion, 2 months after inclusion, 10 months and 3 years after randomization
at inclusion, 2 months after inclusion, 10 months and 3 years after randomization
Rate of patients without event
Time Frame: at 5 years following randomization
at 5 years following randomization
Rate of events adjusted on the initial lymph node status
Time Frame: at 3 and 5 years following randomization
at 3 and 5 years following randomization
Recurrence rate (histologically proven)
Time Frame: at 3 years following randomization and then at 5 years
at 3 years following randomization and then at 5 years
Rate of cure after an event
Time Frame: at 5 years after randomization
at 5 years after randomization
Cost of treatment and follow-up
Time Frame: at 3 years after randomization
at 3 years after randomization
Rate of events adjusted on tumoral molecular characterization
Time Frame: 3 and 5 years after randomization
3 and 5 years after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-A01569-34
  • 2012/1913 (Other Identifier: CSET number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Risk Differentiated Thyroid Cancer

Clinical Trials on rhTSH stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings