Using radiotherapy alongside radioiodine for high-risk thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III randomized controlled clinical trial investigates the effectiveness of adjuvant radiotherapy combined with radioiodine treatment in patients with high-risk locally advanced differentiated thyroid cancer. Participants are randomly assigned to receive either the combination treatment or radioiodine alone, with the primary goal of assessing local recurrence-free survival (LRFS). The study aims to determine if adding radiotherapy can improve outcomes for patients who have undergone incomplete surgical resection of their tumors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient voluntarily joined this study and signed an informed consent form;
2. Age: ≥ 14 years old,\<80 years old, male or female not limited;
3. Histopathological diagnosis of differentiated thyroid cancer;
4. Surgical total or near total thyroidectomy;
5. The surgery did not achieve R0 resection, and R1/ R2 resection was performed. The volume of residual tumor in R2 resected patients is less than 2cm3;
6. The main organ functions are normal;
7. Good compliance and cooperation with follow-up.

Exclusion Criteria:

1. Previously received radiation therapy for the head and neck area;
2. Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
3. There is distant metastasis;
4. Previously received 131I treatment;
5. Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
6. Within 5 years or simultaneously suffering from other active malignant tumors. Cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, can be included in the group;
7. Pregnant or lactating women;
8. Other physical illnesses that affect patients' ability to receive standard treatment;
9. According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data;
10. Individuals with claustrophobia who are unable to undergo radiation therapy;
11. Patients deemed unsuitable for inclusion by other attending physicians.

Where it's running

• Fudan Univeristy Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Naisi Huang, M.D.
• Email: huangnaisi@fudan.edu.cn
• Phone: 86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.