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NCT Number: NCT07777536

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

To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer

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Key information

Conditions

Thyroid Cancer Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Carcinoma, Anaplastic Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

Selective coverage radiotherapy

Radiation
  • 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 radiotherapy

Radiation
  • 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）.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Progression Free Survival，PFS

    Time frame: 12 months

    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.

  2. Overall Survival, OS

    Time frame: 12 months

    The time from randomization to death due to any cause.

  3. Disease Control Rate，DCR

    Time frame: up to 12 months

    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.

  4. Adverse Events

    Time frame: 12 months

    All radiotherapy-related adverse events will be documented

  5. Quality of Life (QoL) by EORTC QLQ-H&N35 questionnaire.

    Time frame: 12 months

    Changes in QoL of participants from baseline to up to 12 months after the radiotherapy. Use EORTC QLQ-H&N35 questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Fen Xue, MD

CONTACT

[email protected]

Xiayun He, MD

CONTACT

[email protected]

+86021-64175590-81412

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer: A Randomized, Controlled, Non-inferiority, Phase 2 Study

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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