RecruitingPhase 3NCT06558981

Adjuvant Radiotherapy in High Risk Locally Advanced DTC

The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer:a 1:1 Randomized Phase III Clinical Trial


Sponsor

Fudan University

Enrollment

124 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adjuvant radiation therapy (given after surgery) benefits patients with differentiated thyroid cancer — such as papillary or follicular thyroid cancer — that is considered high-risk and locally advanced, where surgery was unable to completely remove all the cancer. **You may be eligible if...** - You are aged 14–79 with a confirmed diagnosis of differentiated thyroid cancer - You had a total or near-total thyroidectomy (surgery to remove the thyroid) - Surgery did not remove all the cancer (incomplete or R1/R2 resection), with residual tumor less than 2cm³ in volume - Your major organ functions are normal **You may NOT be eligible if...** - You have already had head or neck radiation therapy - Your cancer has spread to distant parts of the body - You have received prior radioactive iodine (I-131), targeted therapy, immunotherapy, or chemotherapy - You are pregnant or breastfeeding - You have another active cancer within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

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.

OTHERradioiodine treatment

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


Locations(1)

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

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NCT06558981


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