Thyroid CancerPhase 3NCT06558981
Adjuvant Radiotherapy in High Risk Locally Advanced DTC
A Phase 3 study testing Radiotherapy and radioiodine treatment in people with Thyroid Cancer, run by Fudan University at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Radiotherapy and radioiodine treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2024to Jun 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient voluntarily joined this study and signed an informed consent form;
- Age: ≥ 14 years old,<80 years old, male or female not limited;
- Histopathological diagnosis of differentiated thyroid cancer;
- Surgical total or near total thyroidectomy;
- 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;
- The main organ functions are normal;
- Good compliance and cooperation with follow-up.
Who cannot join
- Previously received radiation therapy for the head and neck area;
- Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
- There is distant metastasis;
- Previously received 131I treatment;
- Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
- 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;
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- Pregnant or lactating women;
- Other physical illnesses that affect patients' ability to receive standard treatment;
- 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;
- Individuals with claustrophobia who are unable to undergo radiation therapy;
- Patients deemed unsuitable for inclusion by other attending physicians.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Univeristy Shanghai Cancer Center
Shanghai
Yu Wang, M.D., 86-021-64175590 ext. 65805, neck130@hotmail.com
About this study
Official title: The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer：a 1:1 Randomized Phase III Clinical Trial
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
- Being tested
- Radiotherapy, radioiodine treatment
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
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 treatmentOther
RAI would be delivered based on the condition of residual lesions after surgery. The treatment window is within 6 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + RAI | Experimental | Patients in the experimental group would receive radiotherapy and RAI. Receives: Radiation: Radiotherapy; Other: radioiodine treatment |
| RAI | Active comparator | Patients in the control group would receive RAI. Receives: Other: radioiodine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local-regional Recurrence Free Survival （LRFS）
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.
Measured: 5 years after surgery
Secondary outcomes (6)
Local-regional Recurrence Rate，LRR
The percentage of patients with local-regional recurrence in the total number of patients.
Measured: 5 years after surgery
Progression Free Survival，PFS
The time from surgery to tumor progression, including local recurrence and distant metastasis.
Measured: 5 years after surgery
Overall Survival，OS
The time from surgery to patient death.
Measured: 5 years after surgery
Adverse Events，AE
The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with radiotherapy;
Measured: 5 years after surgery
Quality of Life as assessed by QLQ-H&N35
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) .
Measured: 5 years after surgery
Quality of Life as assessed by QLQ-C30
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.
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start11 Jul 2024
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558981
- Sponsor's protocol ID
- ARAD-TC
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer：a 1:1 Randomized Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT06558981
- Acronym / sponsor ID
- ARAD-TC
- Conditions
- Thyroid Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + RAI | Experimental | Radiation: Radiotherapy, Other: radioiodine treatmentPatients in the experimental group would receive radiotherapy and RAI. |
| RAI | Active comparator | Other: radioiodine treatmentPatients in the control group would receive RAI. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- The patient voluntarily joined this study and signed an informed consent form;
- Age: ≥ 14 years old,<80 years old, male or female not limited;
- Histopathological diagnosis of differentiated thyroid cancer;
- Surgical total or near total thyroidectomy;
- 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;
Key exclusion criteria (11 listed)
- Previously received radiation therapy for the head and neck area;
- Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
- There is distant metastasis;
- Previously received 131I treatment;
- Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyPpatients 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. | Radiation | Radiotherapy + RAI |
| radioiodine treatmentRAI would be delivered based on the condition of residual lesions after surgery. The treatment window is within 6 months after surgery. | Other | RAI, Radiotherapy + RAI |
Primary outcome
Local-regional Recurrence Free Survival （LRFS）
Time frame: 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.
6 secondary outcomes
Local-regional Recurrence Rate，LRR
Time frame: 5 years after surgery
Progression Free Survival，PFS
Time frame: 5 years after surgery
Overall Survival，OS
Time frame: 5 years after surgery
Adverse Events，AE
Time frame: 5 years after surgery
Quality of Life as assessed by QLQ-H&N35
Time frame: 5 years after surgery
Quality of Life as assessed by QLQ-C30
Time frame: 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy and radioiodine treatment in people with Thyroid Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naisi Huang, M.D. (86-021-64175590 ext. 67816, huangnaisi@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local-regional Recurrence Free Survival （LRFS） (time frame: 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.