Thyroid CancerPhase 2NCT07777536
Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer
A Phase 2 study testing Selective coverage radiotherapy and comprehensive coverage radiotherapy in people with Thyroid Cancer, run by Fudan University at 1 site in China.
Trial summary
To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Selective coverage radiotherapy and comprehensive coverage radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2026to 31 Jul 2032
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Pathologically confirmed as ATC, thyroid cancer containing ATC components, PDTC (in accordance with Turin criteria), or other thyroid cancers with poorly differentiated components, and the MDT considers the biological behavior similar to PDTC.
- Evaluated by the MDT and proposed to receive external beam radiotherapy, including postoperative R0/R1, R2 gross residual, inoperable local lesion, and local recurrence.
- ECOG performance status 0-2
- expected survival ≥ 3 months
- major organ functions can meet the requirements for radiotherapy and the proposed systemic treatment.
- The subject voluntarily participates in the study and signs a written informed consent form, willing to follow up according to the protocol and fill in the quality of life scale.
Who cannot join
- Has received radiotherapy to the head and neck or upper mediastinum region in the past, and the target area of this study overlaps significantly with it, and the normal tissue limit cannot be met.
- Has severe uncontrolled infections, active bleeding, unaddressed airway crises, severe dysfunction of the heart, lungs, liver, kidneys or other diseases that cannot be safely treated with radiotherapy.
- Pregnant or lactating women; women of childbearing age who do not agree to take effective contraceptive measures.
- Has other active malignant tumors within 5 years or simultaneously (excluding cured localized 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, etc.)
- Cannot complete radiotherapy fixation, simulation positioning or follow-up imaging assessment.
- Other situations that the researcher deems unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fen Xue, MD contact
China1 site, 1 recruiting
- Recruiting
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiayun He, MD, +86021-64175590-81412, hexiayun1962@163.com
Fen Xue, MD, dr_fenxue@163.com
About this study
Official title: Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer: A Randomized, Controlled, Non-inferiority, Phase 2 Study
To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer
Read the detailed description
To explore that selective coverage radiotherapy is non-inferior to comprehensive coverage radiotherapy in terms of locoregional control rate at 12 months in poorly differentiated and anaplastic thyroid cancer, while reducing radiotherapy-related toxicity and improving quality of life.
- Conditions
- Thyroid Cancer
- Being tested
- Selective coverage radiotherapy, comprehensive coverage radiotherapy
- Keywords
- poorly differentiated thyroid cancer, anaplastic thyroid cancer, selective coverage radiotherapy, locoregional control, radiotherapy-related toxicity
- Medical subject headings
- Thyroid Neoplasms, Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective coverage radiotherapyRadiation
- GTV or GTV tb 66-70Gy/33-35Fx
- High-risk CTV 60Gy: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy；The lymphatic drainage areas where the positive lymph nodes are located, can also be regarded as high-risk CTVs according to MDT decision.
comprehensive coverage radiotherapyRadiation
- GTV or GTV tb 66-70Gy/33-35Fx
- CTV: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy（60 Gy）；prophylactic irradiation was performed on the bilateral neck II-VI regions and upper mediastinum regions based on the extent of lymph node invasion, and the dose was determined according to the risk stratification（54-60Gy）.
| Study group | Role | What they receive |
|---|---|---|
| Selective coverage radiotherapy | Experimental | Not described Receives: Radiation: Selective coverage radiotherapy |
| comprehensive coverage radiotherapy | Active comparator | Not described Receives: Radiation: comprehensive coverage radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control rate，LRC
The time from the randomization date to the first occurrence of locoregional progression/recurrence. Locoregional regions include the primary thyroid lesion or the postoperative tumor bed, the central region/upper mediastinal related regions, the cervical lymph node region, the retropharyngeal lymph nodes, and the cervical soft tissue contiguous with the original lesion. 12-month LRC is defined as 1 minus the cumulative incidence of locoregional progression over 12 months.
Measured: 12 months
Secondary outcomes (5)
Progression Free Survival，PFS
From the date of randomization to the date of the first recording of tumor PD (evaluated according to the RECIST 1.1) or the date of death due to any cause, whichever comes earlier. PD includes local regional recurrence/progression and distant metastasis.
Measured: 12 months
Overall Survival, OS
The time from randomization to death due to any cause.
Measured: 12 months
Disease Control Rate，DCR
Defined as the proportion of patients with a complete response, partial response and stable Disease to radiotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST). Applicable to those with measurable lesions.
Measured: up to 12 months
Adverse Events
All radiotherapy-related adverse events will be documented
Measured: 12 months
Quality of Life (QoL) by EORTC QLQ-H&N35 questionnaire.
Changes in QoL of participants from baseline to up to 12 months after the radiotherapy. Use EORTC QLQ-H\&N35 questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start12 Aug 2026
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2032 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777536
- Sponsor's protocol ID
- SCOPE
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer: A Randomized, Controlled, Non-inferiority, Phase 2 Study
- ClinicalTrials.gov ID
- NCT07777536
- Acronym / sponsor ID
- SCOPE
- Conditions
- Thyroid Cancer
- Keywords
- poorly differentiated thyroid cancer, anaplastic thyroid cancer, selective coverage radiotherapy, locoregional control, radiotherapy-related toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 20 Aug 2026 (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.
To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer
Detailed description
To explore that selective coverage radiotherapy is non-inferior to comprehensive coverage radiotherapy in terms of locoregional control rate at 12 months in poorly differentiated and anaplastic thyroid cancer, while reducing radiotherapy-related toxicity and improving quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective coverage radiotherapy | Experimental | Radiation: Selective coverage radiotherapy |
| comprehensive coverage radiotherapy | Active comparator | Radiation: comprehensive coverage radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Pathologically confirmed as ATC, thyroid cancer containing ATC components, PDTC (in accordance with Turin criteria), or other thyroid cancers with poorly differentiated components, and the MDT considers the biological behavior similar to PDTC.
- Evaluated by the MDT and proposed to receive external beam radiotherapy, including postoperative R0/R1, R2 gross residual, inoperable local lesion, and local recurrence.
- ECOG performance status 0-2
- expected survival ≥ 3 months
Key exclusion criteria (6 listed)
- Has received radiotherapy to the head and neck or upper mediastinum region in the past, and the target area of this study overlaps significantly with it, and the normal tissue limit cannot be met.
- Has severe uncontrolled infections, active bleeding, unaddressed airway crises, severe dysfunction of the heart, lungs, liver, kidneys or other diseases that cannot be safely treated with radiotherapy.
- Pregnant or lactating women; women of childbearing age who do not agree to take effective contraceptive measures.
- Has other active malignant tumors within 5 years or simultaneously (excluding cured localized 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, etc.)
- Cannot complete radiotherapy fixation, simulation positioning or follow-up imaging assessment.
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 |
|---|---|---|
| Selective coverage radiotherapy1. GTV or GTV tb 66-70Gy/33-35Fx 2. High-risk CTV 60Gy: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy；The lymphatic drainage areas where the positive lymph nodes are located, can also be regarded as high-risk CTVs according to MDT decision. | Radiation | Selective coverage radiotherapy |
| comprehensive coverage radiotherapy1. GTV or GTV tb 66-70Gy/33-35Fx 2. CTV: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy（60 Gy）；prophylactic irradiation was performed on the bilateral neck II-VI regions and upper mediastinum regions based on the extent of lymph node invasion, and the dose was determined according to the risk stratification（54-60Gy）. | Radiation | comprehensive coverage radiotherapy |
Primary outcome
Locoregional control rate，LRC
Time frame: 12 months
The time from the randomization date to the first occurrence of locoregional progression/recurrence. Locoregional regions include the primary thyroid lesion or the postoperative tumor bed, the central region/upper mediastinal related regions, the cervical lymph node region, the retropharyngeal lymph nodes, and the cervical soft tissue contiguous with the original lesion. 12-month LRC is defined as 1 minus the cumulative incidence of locoregional progression over 12 months.
5 secondary outcomes
Progression Free Survival，PFS
Time frame: 12 months
Overall Survival, OS
Time frame: 12 months
Disease Control Rate，DCR
Time frame: up to 12 months
Adverse Events
Time frame: 12 months
Quality of Life (QoL) by EORTC QLQ-H&N35 questionnaire.
Time frame: 12 months
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Fen Xue, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selective coverage radiotherapy and comprehensive coverage radiotherapy 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 6 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 20 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiayun He, MD (+86021-64175590-81412, hexiayun1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control rate，LRC (time frame: 12 months). 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 20 Aug 2026.