Stereotactic Body Radiotherapy for the Treatment of Distant Metastases in Thyroid Cancer: A Phase II Prospective Clinical Study

Enrolling by invitation

Conditions studied: Thyroid Cancer Stage IV

In brief

The goal of this observational study is to evaluate the efficacy and safety of Stereotactic Body Radiotherapy in the treatment of distant metastatic thyroid cancer.

Key facts

Study ID

NCT07755423

Run by

Fudan University

People needed

44

Starts

2026-04-01

Expected to finish

2030-12-31

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with primary lesion pathologically confirmed as thyroid cancer, and distant metastatic lesions confirmed either by pathology or by two types of imaging modalities. Based on the investigator's judgment, the participant's distant metastatic lesions are expected to be tolerable to Stereotactic Body Radiotherapy (SBRT). The distant metastases should be oligometastatic (total number of metastatic lesions ≤ 5).
• Participants who have failed prior systemic therapy. Systemic therapy includes radioactive iodine therapy, immunotherapy, targeted therapy, clinical trial therapy, etc.
• Age: 18 - 70 years old.
• KPS ≥ 70.
• Expected survival period ≥ 3 months.
• Before treatment, neutrophils ≥ 1.6 × 109/L, hemoglobin ≥ 80g/L, platelets ≥ 80×109/L; creatinine clearance rate ≥ 60 ml/min; non-hepatic metastasis patients (total bilirubin ≤ 1.5 times the upper limit of normal, ALT ≤ 1.5 times the upper limit of normal, AST ≤ 1.5 times the upper limit of normal), hepatic metastasis patients (total bilirubin ≤ 3 times the upper limit of normal, ALT ≤ 3 times the upper limit of normal, AST ≤ 3 times the upper limit of normal, normal coagulation function, Child-Pugh grade A or B, normal liver tissue volume > 700 mL)
• Signed informed consent form and willing to complete the study according to the protocol.

You may not qualify if…

• Patients who achieved complete remission after comprehensive treatment.
• Pathologically confirmed as a second primary tumor.
• Received radiotherapy to the corresponding area and the radiotherapy site overlapped with this one.
• Uncontrollable malignant pleural or peritoneal effusion.
• Severe internal medical complications and contraindications to radiotherapy.
• Pregnant women of childbearing age with positive pregnancy test or lactating women.
• Active mental disorders or other psychological disorders that affected the patient's signing of informed consent and understanding ability.
• Uncontrollable infections or active infections, such as immunodeficiency or AIDS patients.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, China

Full record on ClinicalTrials.gov

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