Fudan Univeristy Shanghai Cancer Center
Shanghai, China
Location status: Recruiting
NCT Number: NCT06558981
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.
Interested in participating?
Request Info14 year–80 year
All sexes
Interventional
Phase 3
Shanghai, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 5 years after surgery
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
The percentage of patients with local-regional recurrence in the total number of patients.
Time frame: 5 years after surgery
The time from surgery to tumor progression, including local recurrence and distant metastasis.
Time frame: 5 years after surgery
The time from surgery to patient death.
Time frame: 5 years after surgery
The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with radiotherapy;
Time frame: 5 years after surgery
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
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.
Contact information is provided by the study sponsor or research team.
Fudan University
Other
The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer:a 1:1 Randomized Phase III Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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