Adjuvant Radiotherapy in High Risk Locally Advanced DTC

Last updated: August 14, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

3

Condition

Thyroid Cancer

Treatment

radioiodine treatment

Radiotherapy

Clinical Study ID

NCT06558981
ARAD-TC
  • Ages 14-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient voluntarily joined this study and signed an informed consent form;

  2. Age: ≥ 14 years old,<80 years old, male or female not limited;

  3. Histopathological diagnosis of differentiated thyroid cancer;

  4. Surgical total or near total thyroidectomy;

  5. The surgery did not achieve R0 resection, and R1/ R2 resection was performed. Thevolume of residual tumor in R2 resected patients is less than 2cm3;

  6. The main organ functions are normal;

  7. Good compliance and cooperation with follow-up.

Exclusion

Exclusion Criteria:

  1. Previously received radiation therapy for the head and neck area;

  2. Differentiated thyroid cancer with poorly differentiated, or undifferentiatedcomponents;

  3. There is distant metastasis;

  4. Previously received 131I treatment;

  5. Previously received or currently receiving targeted therapy, immunotherapy,chemotherapy;

  6. Within 5 years or simultaneously suffering from other active malignant tumors. Curedlocal 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;

  7. Pregnant or lactating women;

  8. Other physical illnesses that affect patients' ability to receive standardtreatment;

  9. According to the researchers' assessment, there may be other factors that couldforce the subjects to terminate the study, such as suffering from other seriousillnesses (including mental illnesses) that require concurrent treatment, severeabnormal laboratory test values, family or social factors that may affect the safetyof the subjects or the collection of experimental data;

  10. Individuals with claustrophobia who are unable to undergo radiation therapy;

  11. Patients deemed unsuitable for inclusion by other attending physicians.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: radioiodine treatment
Phase: 3
Study Start date:
July 11, 2024
Estimated Completion Date:
June 30, 2031

Connect with a study center

  • Fudan Univeristy Shanghai Cancer Center

    Shanghai,
    China

    Active - Recruiting

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