RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer

Recruiting

• Conditions: Thyroid Cancer
• Interventions: Radiation: adjuvant radiotherapy

• Registration Number: NCT06524167
• Lead Sponsor: Fudan University

Brief Summary

This study is a real-world study to observe the role of adjuvant radiotherapy in locally advanced recurrent high-risk thyroid cancer. The study included thyroid cancer that requires adjuvant radiotherapy to increase local control rate, excluding undifferentiated cancer. Local-regional recurrence free survival is the primary endpoint of the study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-02
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-27
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2031-06-30
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adjuvant radiotherapy	adjuvant radiotherapy	Locally advanced recurrent high-risk thyroid cancer patients who had adjuvant radiotherapy.

Primary Outcome Measures

Name	Time	Method
LRRFS	5 years	Local-regional Recurrence Free Survival

Secondary Outcome Measures

Name	Time	Method
PFS	5 years	Progression Free Survival
OS	5 years	Overall Survival
AE	5 years	Adverse Events
QoL	5 years	Quality of Life
DCR	5 years	Disease Control Rate

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China