NCT00435851

Brief 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. 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 It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn).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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
Last Updated

February 19, 2007

Status Verified

February 1, 2007

First QC Date

February 15, 2007

Last Update Submit

February 16, 2007

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • the rate of successful postoperative thyroid ablation

Secondary Outcomes (4)

  • the rate of long-term complications

  • specific toxicities

  • management costs (hospitalization, diagnosis tests and sick leave)

  • quality of life and utility

Interventions

Thyrogen, thyroid hormone withdrawal, iode 131DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (2)

  • 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.

    PMID: 29807824DERIVED

  • 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.

    PMID: 22551127DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Thyrotropin Alfa

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

ThyrotropinPituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Martin SCHLUMBERGER, PhD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin SHCLUMBERGER, PhD

CONTACT

00 33 014-211-6095schlumbg@igr.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 16, 2007

Study Start

February 1, 2007

Last Updated

February 19, 2007

Record last verified: 2007-02

Locations

FR(1)