ClinicalTrials.gg
RecruitingNCT07777536Updated Aug 20, 2026

Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer

A Phase 2 interventional study of Selective coverage radiotherapy and comprehensive coverage radiotherapy in Thyroid Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Thyroid Cancer

Keywords

  • poorly differentiated thyroid cancer
  • anaplastic thyroid cancer
  • selective coverage radiotherapy
  • locoregional control
  • radiotherapy-related toxicity
03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 72 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years old
  • 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.
  • 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 form, willing to follow up according to the protocol and fill in the quality of life scale.

Exclusion criteria

Exclusion Criteria:

  • 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Selective coverage radiotherapy

    Radiation: Selective coverage radiotherapy

  • Active comparator
    comprehensive coverage radiotherapy

    Radiation: comprehensive coverage radiotherapy

Interventions

  • RadiationSelective coverage radiotherapy

    1. 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.

  • Radiationcomprehensive coverage radiotherapy

    1. 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. Overall Survival, OS

    The time from randomization to death due to any cause.

    Time frame: 12 months

  3. 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.

    Time frame: up to 12 months

  4. Adverse Events

    All radiotherapy-related adverse events will be documented

    Time frame: 12 months

  5. 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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2031, 59 months after the start.

Of 77 non-industry phase 2 interventional studies under Thyroid Neoplasms, half reached primary completion within 84 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 124. This study's planned 59 months is below that.

Counting every sponsor, half of 92 studies reached it within 73 months; a quarter within 39 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2026
First posted
Aug 20, 2026
StartActual
Aug 12, 2026
Primary completionEst.
Jul 31, 2031
CompletionEst.
Jul 31, 2032
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07777536
Lead sponsor
Fudan University
Responsible party
Chaosu Hu (Principal Investigator, Fudan University) — Principal investigator
First posted
Aug 20, 2026
Start date
Aug 12, 2026
Primary completion
Jul 31, 2031 (estimated)
Completion
Jul 31, 2032 (estimated)
Last update
Aug 20, 2026

Study contacts

Xiayun He, MD
Contact
hexiayun1962@163.com
+86021-64175590-81412
Fen Xue, MD
Contact
dr_fenxue@163.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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