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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
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.
RAI would be delivered based on the condition of residual lesions after surgery. The treatment window is within 6 months after surgery.
Fudan Univeristy Shanghai Cancer Center
Shanghai, China
RECRUITINGLocal-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.
Time frame: 5 years after surgery
Local-regional Recurrence Rate,LRR
The percentage of patients with local-regional recurrence in the total number of patients.
Time frame: 5 years after surgery
Progression Free Survival,PFS
The time from surgery to tumor progression, including local recurrence and distant metastasis.
Time frame: 5 years after surgery
Overall Survival,OS
The time from surgery to patient death.
Time frame: 5 years after surgery
Adverse Events,AE
The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with radiotherapy;
Time frame: 5 years after surgery
Quality of Life as assessed by QLQ-H&N35
Patients in the experimental group were evaluated for QoL within 1 week before the start of radiotherapy, 1 week after the end of radiotherapy, 3 months after the end of radiotherapy, and 1, 3, and 5 years after surgery. The control group patients were evaluated for QoL at 1 month, 3 months, 1 year, 3 years, and 5 years after surgery. The QoL evaluation scale adopts the EORTC Quality of Life Measurement Scale QLQ-H\&N35 (V1.0) .
Time frame: 5 years after surgery
Quality of Life as assessed by QLQ-C30
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Patients in the experimental group were evaluated for QoL within 1 week before the start of radiotherapy, 1 week after the end of radiotherapy, 3 months after the end of radiotherapy, and 1, 3, and 5 years after surgery. The control group patients were evaluated for QoL at 1 month, 3 months, 1 year, 3 years, and 5 years after surgery. The QoL evaluation scale adopts the EORTC Quality of Life Measurement Scale QLQ-C30 (V3.0) Chinese version.
Time frame: 5 years after surgery