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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy + RAI | Experimental | Patients in the experimental group would receive radiotherapy and RAI. |
|
| RAI | Active Comparator | Patients in the control group would receive RAI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Local-regional Recurrence Rate,LRR | The percentage of patients with local-regional recurrence in the total number of patients. | 5 years after surgery |
| Progression Free Survival,PFS | The time from surgery to tumor progression, including local recurrence and distant metastasis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naisi Huang, M.D. | Contact | 86-021-64175590 | 67816 | huangnaisi@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Univeristy Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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. |
|
| 5 years after surgery |
| Overall Survival,OS | The time from surgery to patient death. | 5 years after surgery |
| Adverse Events,AE | The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with radiotherapy; | 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) . | 5 years after surgery |
| Quality of Life as assessed by QLQ-C30 | 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. | 5 years after surgery |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |