metastatic thyroid cancer MedDRA version: 20.0 Level: PT Classification code 10076603 Term: Poorly differentiated thyroid carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Ioduro 124 Sodico
Product Name: Ioduro 124 sodico
Product Code: [124INaI]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: SODIO IODURO
Current Sponsor code:
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present study aims to optimize the nuclear medicine therapeutic approach (radioiodine treatment) to metastatic DTC and to deepen the knowledge on 131I inefficacy. Lesion dosimetry and biological characterization are necessary for both purposes. We therefore propose a twofold path: •to investigate if dosimetry-based 131I administration may increase efficacy as compared to that obtained with fixed activity, with an acceptable toxicity in DTC patients with soft tissue and skeletal metastasis •to study if the mutational status, the gene expression and the variations of miRNA profiles before and after therapy of DTCs may be related to lesions’ refractoriness, even to personalized, 131I therapy;Secondary Objective: NA;Primary end point(s): Evaluation of complete response (CR) rate on soft tissue metastases to radioiodine therapy optimized with personalized pre-treatment dosimetry based on 124I-PET/CT. The best response will be considered.;Timepoint(s) of evaluation of this end point: 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of: • acute toxicity rate and severity • the association among pre-treatment glucose metabolism, 124I uptake and therapy response • the association among genetic mutations on cancer tissue, pre- and post-treatment miRNA expression, pre- and post-treatment glucose metabolism, iodine uptake, and 131I therapy response;Timepoint(s) of evaluation of this end point: 4 years | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione IRCCS Istituto nazionale dei Tumori
Outcome results
None listed