Adjuvant Radiotherapy in High Risk Locally Advanced DTC

NCT06558981 | Recruiting Phase 3

• 1 other identifier: ARAD-TC
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase III randomized controlled clinical trial on the role of adjuvant radiotherapy in high-risk locally advanced differentiated thyroid cancer. Patients who meet the inclusion criteria were randomly assigned 1:1 to either the experimental group (adjuvant radiotherapy+RAI) or the control group (RAI), with LRFS as the primary endpoint of the study.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Local-regional Recurrence Free Survival （LRFS）

  The time from surgery to the occurrence of local-regional tumor recurrence based on the RECIST 1.1. The definition of local areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.

  5 years after surgery

Secondary Outcomes (6)

• Local-regional Recurrence Rate，LRR

  5 years after surgery

• Progression Free Survival，PFS

  5 years after surgery

• Overall Survival，OS

  5 years after surgery

• Adverse Events，AE

  5 years after surgery

• Quality of Life as assessed by QLQ-H&N35

  5 years after surgery

Study Arms (2)

Radiotherapy + RAI

EXPERIMENTAL

Patients in the experimental group would receive radiotherapy and RAI.

Radiation: Radiotherapy; Other: radioiodine treatment

RAI

ACTIVE COMPARATOR

Patients in the control group would receive RAI.

Other: radioiodine treatment

Interventions

radioiodine treatment OTHER

RAI would be delivered based on the condition of residual lesions after surgery. The treatment window is within 6 months after surgery.

RAI; Radiotherapy + RAI

Radiotherapy RADIATION

Ppatients would receive external radiation therapy within 6 weeks after surgery, using intensity-modulated radiation therapy (IMRT) or volume modulated radiation therapy (VMAT) techniques. RAI would be administered as standard care. The treatment window is within 6 months after surgery.

Radiotherapy + RAI

Eligibility Criteria

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

You may qualify if:

• The patient voluntarily joined this study and signed an informed consent form;
• Age: ≥ 14 years old,\<80 years old, male or female not limited;
• Histopathological diagnosis of differentiated thyroid cancer;
• Surgical total or near total thyroidectomy;
• 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;
• The main organ functions are normal;
• Good compliance and cooperation with follow-up.

You may not qualify if:

• Previously received radiation therapy for the head and neck area;
• Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
• There is distant metastasis;
• Previously received 131I treatment;
• Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
• 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;
• Pregnant or lactating women;
• Other physical illnesses that affect patients' ability to receive standard treatment;
• 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;
• Individuals with claustrophobia who are unable to undergo radiation therapy;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Naisi Huang, M.D.

CONTACT

86-021-64175590; huangnaisi@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 19, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)