Using radiotherapy alongside radioiodine for high-risk thyroid cancer
The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer：a 1:1 Randomized Phase III Clinical Trial
This study tests if adding radiotherapy to radioiodine treatment can help people with high-risk thyroid cancer live longer without their cancer coming back after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06558981 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 79 with a histopathological diagnosis of differentiated thyroid cancer who have undergone incomplete surgical resection.
Not a fit: Patients with distant metastasis, poorly differentiated thyroid cancer, or those who have previously received radiation therapy or other cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce the risk of cancer recurrence in high-risk thyroid cancer patients.
How similar studies have performed: Other studies have explored the role of radiotherapy in thyroid cancer, but this specific combination approach is less commonly tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.