Trial Information
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Inclusion Criteria:
- 18 -75 years
- Karnofsky ≥ 70%
- Histological diagnosis of medullary thyroid carcinoma
- Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years
- Normal liver and renal functions
- Granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3
- No immunization
- Consent form signed
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Francoise Bodere, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CHU de Nantes
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
BRD 03/2-U
NCT ID:
NCT00467506
Start Date:
May 2004
Completion Date:
January 2011
Related Keywords:
- Thyroid Neoplasms
- Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery
- Neoplasms
- Carcinoma
- Thyroid Neoplasms
- Thyroid Diseases