Status:
UNKNOWN
Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 ablatio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
950 Patients enrolled
Trial Details
Trial ID
NCT00435851
Start Date
February 1 2007
Last Update
February 19 2007
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800