Status:
COMPLETED
Multicenter Study Differentiated Thyroid Carcinoma
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Thyroid Neoplasms
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
The trial examines the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated carcinoma (TNM stages pT4 pN0/1/x M0/x; 5th ed. 1997) of the thyroid gland (DTC...
Detailed Description
MSDS was designed as a comprehensive cohort trial with randomization and observation arms. Patients are enrolled at the time of the first ablative radioiodine therapy (RIT). Inclusion criteria are pap...
Eligibility Criteria
Inclusion
- papillary or follicular thyroid carcinoma pT4 pN0/1/x M0/x
- completion of primary surgical therapy with R0 (no tumor residues) or R1 (microscopic residues) resection
- Karnofsky index \> 70 %
- freedom from distant metastases at the time of initial radioiodine therapy
- informed patient consent
Exclusion
- secondary malignancy except basalioma
- pregnancy
- serious general disease
- serious psychiatric disorder
- inability to give informed consent
- previous RTx
- recurrence of previous thyroid cancer
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2010
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00144079
Start Date
January 1 2000
End Date
January 1 2010
Last Update
May 9 2006
Active Locations (10)
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1
Department of Nuclear Medicine
Linz, Austria, 4010
2
Department of Nuclear Medicine, Wien University Hospital
Vienna, Austria, 1090
3
Department of Nuclear Medicine, Cologne University
Cologne, Germany, 50924
4
Department of Nuclear Medicine, University Halle-Wittenberg
Halle, Germany, 06097