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Recruiting NCT06558981

Adjuvant Radiotherapy in High Risk Locally Advanced DTC

Phase III Interventional Thyroid Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy, radioiodine treatment.
Who it may be relevant to
Registry conditions: Thyroid Cancer. Basic parameters: 14 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Local-regional Recurrence Free Survival （LRFS） [Time frame: 5 years after surgery]
Secondary outcome measures (6)
  • Local-regional Recurrence Rate，LRR [Time frame: 5 years after surgery]
  • Progression Free Survival，PFS [Time frame: 5 years after surgery]
  • Overall Survival，OS [Time frame: 5 years after surgery]
  • Adverse Events，AE [Time frame: 5 years after surgery]
  • Quality of Life as assessed by QLQ-H&N35 [Time frame: 5 years after surgery]
  • Quality of Life as assessed by QLQ-C30 [Time frame: 5 years after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan Univeristy Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06558981 · ARAD-TC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗