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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn).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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01837745

Low Risk Differentiated Thyroid Cancer

ACTIVE_NOT_RECRUITING PHASE3

High Dose vs Low Dose I 131 +/- rhTSH for Differentiated Thyroid Cancer

NCT00415233

Head and Neck Cancer

ACTIVE_NOT_RECRUITING PHASE3

rhTSH-Thyroid Ablation With 1850 MBq of 131I

NCT00454077

Thyroid Cancer

COMPLETED

Differentiated Thyroid Cancer Patients Treated With Different Doses of Radioactive Iodine.

NCT06134830

Thyroid Cancer

NOT_YET_RECRUITING

Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

NCT02418247

Thyroid Neoplasms

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thyrogen, thyroid hormone withdrawal, iode 131

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No