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NCT Number: NCT06558981

Adjuvant Radiotherapy in High Risk Locally Advanced DTC

This study is a phase III randomized controlled clinical trial on the role of adjuvant radiotherapy in high-risk locally advanced differentiated thyroid cancer. Patients who meet the inclusion criteria were randomly assigned 1:1 to either the experimental group (adjuvant radiotherapy+RAI) or the control group (RAI), with LRFS as the primary endpoint of the study.

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan Univeristy Shanghai Cancer Center

Shanghai, 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

  • The patient voluntarily joined this study and signed an informed consent form;
  • Age: ≥ 14 years old,<80 years old, male or female not limited;
  • Histopathological diagnosis of differentiated thyroid cancer;
  • Surgical total or near total thyroidectomy;
  • The surgery did not achieve R0 resection, and R1/ R2 resection was performed. The volume of residual tumor in R2 resected patients is less than 2cm3;
  • The main organ functions are normal;
  • Good compliance and cooperation with follow-up.

Exclusion criteria

  • Previously received radiation therapy for the head and neck area;
  • Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
  • There is distant metastasis;
  • Previously received 131I treatment;
  • Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
  • 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;
  • Pregnant or lactating women;
  • Other physical illnesses that affect patients' ability to receive standard treatment;
  • According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study, 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 safety of the subjects or the collection of experimental data;
  • Individuals with claustrophobia who are unable to undergo radiation therapy;
  • Patients deemed unsuitable for inclusion by other attending physicians.

Treatment and study plan

Radiotherapy

Radiation

Ppatients would receive external radiation therapy within 6 weeks after surgery, using intensity-modulated radiation therapy (IMRT) or volume modulated radiation therapy (VMAT) techniques. RAI would be administered as standard care. The treatment window is within 6 months after surgery.

radioiodine treatment

Other

RAI would be delivered based on the condition of residual lesions after surgery. The treatment window is within 6 months after surgery.

Primary outcomes

  1. Local-regional Recurrence Free Survival (LRFS)

    Time frame: 5 years after surgery

    The time from surgery to the occurrence of local-regional tumor recurrence based on the RECIST 1.1. The definition of local areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.

Secondary outcomes

  1. Local-regional Recurrence Rate,LRR

    Time frame: 5 years after surgery

    The percentage of patients with local-regional recurrence in the total number of patients.

  2. Progression Free Survival,PFS

    Time frame: 5 years after surgery

    The time from surgery to tumor progression, including local recurrence and distant metastasis.

  3. Overall Survival,OS

    Time frame: 5 years after surgery

    The time from surgery to patient death.

  4. Adverse Events,AE

    Time frame: 5 years after surgery

    The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with radiotherapy;

  5. Quality of Life as assessed by QLQ-H&N35

    Time frame: 5 years after surgery

    Patients in the experimental group were evaluated for QoL within 1 week before the start of radiotherapy, 1 week after the end of radiotherapy, 3 months after the end of radiotherapy, and 1, 3, and 5 years after surgery. The control group patients were evaluated for QoL at 1 month, 3 months, 1 year, 3 years, and 5 years after surgery. The QoL evaluation scale adopts the EORTC Quality of Life Measurement Scale QLQ-H&N35 (V1.0) .

  6. Quality of Life as assessed by QLQ-C30

    Time frame: 5 years after surgery

    Patients in the experimental group were evaluated for QoL within 1 week before the start of radiotherapy, 1 week after the end of radiotherapy, 3 months after the end of radiotherapy, and 1, 3, and 5 years after surgery. The control group patients were evaluated for QoL at 1 month, 3 months, 1 year, 3 years, and 5 years after surgery. The QoL evaluation scale adopts the EORTC Quality of Life Measurement Scale QLQ-C30 (V3.0) Chinese version.

Study contacts

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

Naisi Huang, M.D.

CONTACT

[email protected]

86-021-64175590 ext. 67816

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer:a 1:1 Randomized Phase III Clinical Trial

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Aug 19, 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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