Therapy with high activity of radioiodine in patients bearing differentiated thyroid cancer

• Conditions: Patients bearing differentiated thyroid carcinoma with distant metastases, candidated to metabolic radiotherapy after surgery or repetition of same therapy; MedDRA version: 14.1Level: PTClassification code 10055107Term: Thyroid cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005248-81-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- diagnosis of differentiated thyroid carcinoma - ECOG performance status of grade 0 or 1 - Age between 18 and 80 years old - Life expectancy of 3 months at least - Fertile women compliance to adopt contraceptive methods for at least 6 months after treatment -Adequate medullar reserve and renal functionality - Eventual second tumor in complete remission for 5 years at least - Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Presence of serious concomitant non neoplastic diseases, not adequately controlled - Pregnancy or breast feeding - Impossibility to follow-up - Concomitant use of nephrotoxic drugs - Surgery or radiotherapy within 2 weeks from beginning of treatment - Pulmonary diffused micrometastases - Extensive skeletal metastases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified