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Trial Title:
Adjuvant Radiotherapy in High Risk Locally Advanced DTC
NCT ID:
NCT06558981
Condition:
Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
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.
Arm group label:
Radiotherapy + RAI
Intervention type:
Other
Intervention name:
radioiodine treatment
Description:
RAI would be delivered based on the condition of residual lesions after surgery. The
treatment window is within 6 months after surgery.
Arm group label:
RAI
Arm group label:
Radiotherapy + RAI
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.
Criteria for 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.
Gender:
All
Minimum age:
14 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan Univeristy Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Wang, M.D.
Phone:
86-021-64175590
Phone ext:
65805
Email:
neck130@hotmail.com
Start date:
July 11, 2024
Completion date:
June 2031
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06558981
