Adjuvant Radiotherapy in High Risk Locally Advanced DTC

Phase 3

Recruiting

• Conditions: Thyroid Cancer
• Interventions: Radiation: Radiotherapy; Other: radioiodine treatment

• Registration Number: NCT06558981
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-11
• Study First Submitted: 2024-07-26
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2031-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. The patient voluntarily joined this study and signed an informed consent form;
2. Age: ≥ 14 years old,<80 years old, male or female not limited;
3. Histopathological diagnosis of differentiated thyroid cancer;
4. Surgical total or near total thyroidectomy;
5. 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;
6. The main organ functions are normal;
7. Good compliance and cooperation with follow-up.

Exclusion Criteria

1. Previously received radiation therapy for the head and neck area;
2. Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
3. There is distant metastasis;
4. Previously received 131I treatment;
5. Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
6. 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;
7. Pregnant or lactating women;
8. Other physical illnesses that affect patients' ability to receive standard treatment;
9. 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;
10. Individuals with claustrophobia who are unable to undergo radiation therapy;
11. Patients deemed unsuitable for inclusion by other attending physicians.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy + RAI	Radiotherapy	Patients in the experimental group would receive radiotherapy and RAI.
Radiotherapy + RAI	radioiodine treatment	Patients in the experimental group would receive radiotherapy and RAI.
RAI	radioiodine treatment	Patients in the control group would receive RAI.

Primary Outcome Measures

Name	Time	Method
Local-regional Recurrence Free Survival （LRFS）	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events，AE	5 years after surgery	The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with radiotherapy;
Overall Survival，OS	5 years after surgery	The time from surgery to patient death.
Quality of Life as assessed by QLQ-C30	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.
Local-regional Recurrence Rate，LRR	5 years after surgery	The percentage of patients with local-regional recurrence in the total number of patients.
Quality of Life as assessed by QLQ-H&N35	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) .
Progression Free Survival，PFS	5 years after surgery	The time from surgery to tumor progression, including local recurrence and distant metastasis.

Trial Locations

Locations (1)

Fudan Univeristy Shanghai Cancer Center; 🇨🇳 Shanghai, China