Adjuvant Radiotherapy in High Risk Locally Advanced DTC

NCT ID: NCT06558981

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2031-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy + RAI

Patients in the experimental group would receive radiotherapy and RAI.

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: 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.

radioiodine treatment

Intervention Type: OTHER

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

RAI

Patients in the control group would receive RAI.

Group Type: ACTIVE_COMPARATOR

radioiodine treatment

Intervention Type: OTHER

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

Interventions

Radiotherapy

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.

Intervention Type: RADIATION

radioiodine treatment

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Yu Wang

Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan Univeristy Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Naisi Huang, M.D.

Role: CONTACT

huangnaisi@fudan.edu.cn

86-021-64175590 ext. 67816

Facility Contacts

Yu Wang, M.D.

Role: primary

neck130@hotmail.com

86-021-64175590 ext. 65805

Other Identifiers

ARAD-TC

Identifier Type: -

Identifier Source: org_study_id