RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Radiation: adjuvant radiotherapy

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Naisi Huang; Phone Number: 67816 86-021-64175590; Email: huangnsisi@fduan.edu.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Yu Wang, M.D.; Phone Number: 65805 86-021-64175590; Email: neck130@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with high recurrence risk locally advanced thyroid cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adjuvant radiotherapy; Locally advanced recurrent high-risk thyroid cancer patients who had adjuvant radiotherapy.	Radiation: adjuvant radiotherapy; The patients would receive external radiation therapy within 6 weeks after surgery, using intensity-modulated radiation therapy (IMRT) or volume modulated radiation therapy (VMAT) techniques. 6MV-X-ray irradiation. Conventional segmented irradiation is used, once a day, five times a week, with a segmented dose of 2Gy per dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LRRFS	Local-regional Recurrence Free Survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	5 years
DCR	Disease Control Rate	5 years
PFS	Progression Free Survival	5 years
AE	Adverse Events	5 years
QoL	Quality of Life	5 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Therapeutics; Radiotherapy; Combined Modality Therapy; Radiotherapy, Adjuvant
• Other Study ID Numbers: AREAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No