Personalized therapy of metastatic thyroid cancer: biological characterization and optimization with 124I PET dosimetry - Progetto AIRC Id. 21939

FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI0 个研究点目标入组 50 人开始时间: 2020年10月22日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•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
•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

•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.

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