RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer

NCT06524167 | Recruiting

• 1 other identifier: AREAL
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• LRRFS

  Local-regional Recurrence Free Survival

  5 years

Secondary Outcomes (5)

• DCR

  5 years

• PFS

  5 years

• OS

  5 years

• AE

  5 years

• QoL

  5 years

Study Arms (1)

Adjuvant radiotherapy

Locally advanced recurrent high-risk thyroid cancer patients who had adjuvant radiotherapy.

Radiation: adjuvant radiotherapy

Interventions

adjuvant radiotherapy RADIATION

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.

Adjuvant radiotherapy

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high recurrence risk locally advanced thyroid cancer

You may qualify if:

• 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:
• The surgery did not achieve R0 resection;
• After neoadjuvant therapy;
• Pathological types with poor prognosis, such as poorly differentiated cancer, CASTLE, etc;
• Thyroid cancer with obvious extracapsular invasion, invading important structures such as the esophagus, trachea, and recurrent laryngeal nerve, requiring adjuvant radiotherapy;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Central Study Contacts

Naisi Huang

CONTACT

86-021-64175590; huangnsisi@fduan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Head-neck surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)