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Thyroid CancerPhase 3EstimablNCT00435851

Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients

A Phase 3 study testing Thyrogen, thyroid hormone withdrawal, iode 131 in people with Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Thyrogen, thyroid hormone withdrawal, iode 131
How many people
950 participants
Where
1 siteFrance
Study dates
Feb 2007to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 year or older
  • Newly diagnosed differentiated papillary or follicular thyroid carcinoma who underwent total thyroidectomy between 30 and 60 days before randomization and treated by LT4 for at least one month.
  • Patients are all staged pT1<1cm N1 or pT1>1cm N0 N1 Nx or pT2 N0
  • The performance status is 0 or 1.
  • All patients will provide written consent to participate.

Who cannot join

  • partial thyroidectomy
  • patients treated by LT4 less than one month
  • time from thyroidectomy superior to 60 days at randomization
  • patients with Hurtle cancer or aggressive histology
  • Patients staged pT1<1cm N0 or T2 N1 or T3 or T4 or M1
  • patients for which the use of rhTSH is required for medical reasons
Show all 11Show fewer
  • patients with major concurrent medical disorder (cardiac, renal, liver, respiratory)
  • patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission for at least 2 years)
  • patients with recent history of drugs affecting thyroid function, including iodine containing medications or radiocontrast agents
  • patients with recent history of 131I whole body scan
  • pregant women or breast-feeding

Trial locations and contacts

1 site in 1 country.

Martin SHCLUMBERGER, PhD contact

00 33 014-211-6095

schlumbg@igr.fr

France1 site

  • Institut Gustave Roussy

    Villejuif, 94800

    Martin SCHLUMBERGER, PhD, 00 33 014-211-6095, schlumbg@igr.fr

Other trials in France

About this study

Official title: Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients - Estimabl

In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff.

Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.

Read the detailed description

This is a multicentric, randomized, controlled, open-label phase III clinical trial involving 26 French centers. It aims at comparing four strategies of management of postoperative radioiodine ablation, each strategy combining a method of TSH stimulation (thyroid hormone withdrawal or rhTSH (Thyrogen®, Genzyme)) and an activity of 131I (low-dose (1GBq, 30 mCi) or high-dose (3,7GBq, 100 mCi)).

Conditions
Thyroid Cancer
Being tested
Thyrogen, thyroid hormone withdrawal, iode 131
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thyrogen, thyroid hormone withdrawal, iode 131Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the rate of successful postoperative thyroid ablation

Secondary outcomes (4)

  1. the rate of long-term complications

  2. specific toxicities

  3. management costs (hospitalization, diagnosis tests and sick leave)

  4. quality of life and utility

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2007 (estimated)
  2. Study startFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
950 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00435851
Sponsor's protocol ID
Estimabl
Other IDs
CSET 1216
Acronym
Estimabl
Status last verified
Feb 2007
First submitted
15 Feb 2007
Last updated
19 Feb 2007
Results posted
No

Publications

  • Schlumberger M, Leboulleux S, Catargi B, Deandreis D, Zerdoud S, Bardet S, Rusu D, Godbert Y, Buffet C, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Toubert ME, Kelly A, Benhamou E, Borget I. Outcome after ablation in patients with low-risk thyroid cancer (ESTIMABL1): 5-year follow-up results of a randomised, phase 3, equivalence trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):618-626. doi: 10.1016/S2213-8587(18)30113-X. Epub 2018 May 26.

    PubMed 29807824

  • Schlumberger M, Catargi B, Borget I, Deandreis D, Zerdoud S, Bridji B, Bardet S, Leenhardt L, Bastie D, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Bonichon F, Dejax C, Toubert ME, Leboulleux S, Ricard M, Benhamou E; Tumeurs de la Thyroide Refractaires Network for the Essai Stimulation Ablation Equivalence Trial. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012 May 3;366(18):1663-73. doi: 10.1056/NEJMoa1108586.

    PubMed 22551127

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thyrogen, thyroid hormone withdrawal, iode 131 in people with Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin SHCLUMBERGER, PhD (00 33 014-211-6095, schlumbg@igr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the rate of successful postoperative thyroid ablation. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00435851, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2007.

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