NCT06558981 Adjuvant Radiotherapy in High Risk Locally Advanced DTC
| NCT ID | NCT06558981 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2031-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 124 participants in total. It began in 2024-07-11 with a primary completion date of 2031-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06558981 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06558981 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 124 participants.
Is NCT06558981 currently recruiting?
Yes, NCT06558981 is actively recruiting participants. Contact the research team at huangnaisi@fudan.edu.cn for enrollment information.
Where is the NCT06558981 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06558981 clinical trial?
NCT06558981 is sponsored by Fudan University. The trial plans to enroll 124 participants.
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