Personalized therapy of metastatic thyroid cancer: biological characterization and optimization with 124I PET dosimetry

Phase 1

• Conditions: metastatic thyroid cancer; MedDRA version: 20.0Level: PTClassification code 10076603Term: Poorly differentiated thyroid carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002548-21-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Histo-pathological diagnosis of DTC
•At least one documented non surgically-curable soft-tissue metastasis previously untreated
•ECOG performance status = 0 - 1
•Age = 18 years old
•Life expectancy > 6 months
•Females of childbearing age must have negative serum pregnancy test prior to registration and agree to use birth control throughout the study and for 6 months after completion
of therapy
•Preserved hematologic and renal function (hemoglobin > 10 g/dL; WBC > 3500/uL; neutrophilis > 50%; PLT > 100000/uL; albumin = 2.5 g/dL; creatinine = 2 mg/dL)
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•All lesions surgically resectable
•Minimal lymph nodal disease (diameter < 1 cm, up to 2 nodes)
•Patient with skeletal metastases only
•Lung diffuse miliary micro-metastases (cannot be assessed according to RECIST criteria; severe lung toxicity may be expected after high activity administration)
•Ongoing pregnancy (enrollment could be considered after delivery)
•Breast-feeding (enrollment could be considered after suspension)
•Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy
•Impossibility to undergo follow-up procedures
•Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects’ ability to complete the protocol
•Assumption of any anti-tumor therapy including chemotherapy, biological or investigational drug treatments
•Assumption of any myelotoxic drugs
•Any other oncologic disease that required treatment in the last 5 years.

Study & Design

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