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

NCT07755423 | Enrolling By Invitation

• 1 other identifier: TC-01
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate，DCR

  3 months

Study Arms (1)

treatment group

radiotherapy

Radiation: SBRT

Interventions

SBRT RADIATION

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).

treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Distant metastasis of thyroid cancer

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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)