Selective coverage radiotherapy vs. full coverage radiotherapy for poorly differentiated and anaplastic thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study compares selective coverage radiotherapy to comprehensive coverage radiotherapy in adults with poorly differentiated or anaplastic thyroid cancer. The goal is to determine non-inferiority in locoregional control at 12 months, with a focus on radiotherapy-related toxicity and patient quality of life. Eligible patients include those with ATC or PDTC-like thyroid cancers, deemed suitable for external beam radiotherapy by a multidisciplinary team. Participants will undergo radiotherapy with specified coverage strategies and will be followed for safety, tumor control, and QoL outcomes. The trial is conducted at Fudan University Shanghai Cancer Center under the lead sponsor Fudan University.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan Universtiy Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiayun He, MD
• Email: hexiayun1962@163.com
• Phone: +86021-64175590-81412

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.