Adjuvant Radiotherapy in High Risk Locally Advanced DTC

Launched by FUDAN UNIVERSITY · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding a type of radiation treatment, called adjuvant radiotherapy, can help patients with high-risk, locally advanced differentiated thyroid cancer after their surgery. In this study, patients who qualify will be randomly placed into one of two groups: one will receive the radiation treatment along with a therapy known as RAI (Radioactive Iodine), while the other group will only receive the RAI. The main goal is to see how well this combination treatment helps prevent the cancer from coming back.

To participate in this trial, patients need to be between the ages of 14 and 80, have been diagnosed with differentiated thyroid cancer, and have recently undergone surgery that did not completely remove the cancer. Other health conditions or previous treatments may exclude some patients from joining. Those who do participate can expect regular follow-up appointments to monitor their health and the effectiveness of the treatment. It's important to know that this study is currently recruiting participants, so there is an opportunity for eligible patients to join and contribute to important cancer research.

Gender

ALL

Eligibility 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.