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NCT Number: NCT06524167

RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer

This study is a real-world study to observe the role of adjuvant radiotherapy in locally advanced recurrent high-risk thyroid cancer. The study included thyroid cancer that requires adjuvant radiotherapy to increase local control rate, excluding undifferentiated cancer. Local-regional recurrence free survival is the primary endpoint of the study.

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location status: Recruiting

Location contact

Yu Wang, M.D.

CONTACT

[email protected]

86-021-64175590 ext. 65805

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients voluntarily join this study and sign an informed consent form;
  • Age: ≥ 14 years old,<80 years old, male or female not limited;
  • Thyroid cancer diagnosed by histopathology, including differentiated thyroid cancer, medullary carcinoma, poorly differentiated carcinoma, etc;
  • High risk of local late recurrence, meeting any of the following criteria:
  • The surgery did not achieve R0 resection;
  • After neoadjuvant therapy;
  • Pathological types with poor prognosis, such as poorly differentiated cancer, CASTLE, etc;
  • Thyroid cancer with obvious extracapsular invasion, invading important structures such as the esophagus, trachea, and recurrent laryngeal nerve, requiring adjuvant radiotherapy;
  • For patients with distant metastasis, researchers need to determine the value of local treatment;
  • The main organ functions are normal;
  • Good compliance and cooperation with follow-up.

Exclusion criteria

  • Untreated thyroid cancer or thyroid cancer that has only undergone surgical biopsy;
  • 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;
  • Previously received radiation therapy for the head and neck area;
  • Pregnant or lactating women;
  • There are other physical illnesses that affect patients' ability to receive standard treatment;
  • According to the researcher's judgment, there may be other factors that could force the subject to terminate the study midway, 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 subject's safety or the collection of trial data;
  • Individuals with claustrophobia who are unable to undergo radiation therapy;
  • Other patients deemed unsuitable for inclusion by the treating physician.

Treatment and study plan

Adjuvant radiotherapy

Radiation

The patients would receive external radiation therapy within 6 weeks after surgery, using intensity-modulated radiation therapy (IMRT) or volume modulated radiation therapy (VMAT) techniques. 6MV-X-ray irradiation. Conventional segmented irradiation is used, once a day, five times a week, with a segmented dose of 2Gy per dose.

Primary outcomes

  1. LRRFS

    Time frame: 5 years

    Local-regional Recurrence Free Survival

Secondary outcomes

  1. DCR

    Time frame: 5 years

    Disease Control Rate

  2. PFS

    Time frame: 5 years

    Progression Free Survival

  3. OS

    Time frame: 5 years

    Overall Survival

  4. AE

    Time frame: 5 years

    Adverse Events

  5. QoL

    Time frame: 5 years

    Quality of Life

Study contacts

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

Naisi Huang

CONTACT

[email protected]

86-021-64175590 ext. 67816

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Real-world Study of Adjuvant Radiotherapy in High Recurrence Risk Locally Advanced Thyroid Cancer

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Jul 29, 2024
Registry last updated
Feb 27, 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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