Observing the effects of radiotherapy in advanced thyroid cancer

A Real-world Study of Adjuvant Radiotherapy in High Recurrence Risk Locally Advanced Thyroid Cancer

This study is testing if adding radiotherapy after surgery can help people with advanced thyroid cancer avoid their cancer coming back.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT06524167 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the role of adjuvant radiotherapy in patients with locally advanced recurrent high-risk thyroid cancer. It focuses on patients who have undergone surgery but are at high risk for local recurrence, specifically those who did not achieve complete resection or have poor prognosis pathological types. The primary endpoint is local-regional recurrence-free survival, which will help determine the effectiveness of radiotherapy in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients aged 14 to 80 with histopathologically confirmed high-risk thyroid cancer requiring adjuvant radiotherapy.

Not a fit: Patients with untreated thyroid cancer or those with undifferentiated cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance local control rates and improve survival outcomes for patients with high-risk thyroid cancer.

How similar studies have performed: Other studies have shown promising results with adjuvant radiotherapy in similar high-risk cancer populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Patients voluntarily join this study and sign an informed consent form;
* Age: ≥ 14 years old,\<80 years old, male or female not limited;
* Thyroid cancer diagnosed by histopathology, including differentiated thyroid cancer, medullary carcinoma, poorly differentiated carcinoma, etc;
* High risk of local late recurrence, meeting any of the following criteria:

  1. The surgery did not achieve R0 resection;
  2. After neoadjuvant therapy;
  3. Pathological types with poor prognosis, such as poorly differentiated cancer, CASTLE, etc;
  4. Thyroid cancer with obvious extracapsular invasion, invading important structures such as the esophagus, trachea, and recurrent laryngeal nerve, requiring adjuvant radiotherapy;
  5. For patients with distant metastasis, researchers need to determine the value of local treatment;
* The main organ functions are normal;
* Good compliance and cooperation with follow-up.

Exclusion Criteria:

* Untreated thyroid cancer or thyroid cancer that has only undergone surgical biopsy;
* 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;
* Previously received radiation therapy for the head and neck area;
* Pregnant or lactating women;
* There are other physical illnesses that affect patients' ability to receive standard treatment;
* According to the researcher's judgment, there may be other factors that could force the subject to terminate the study midway, 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 subject's safety or the collection of trial data;
* Individuals with claustrophobia who are unable to undergo radiation therapy;
* Other patients deemed unsuitable for inclusion by the treating physician.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Naisi Huang

Conditions Thyroid Cancer