Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer

Thyroid Neoplasms Clinical Trial

Official title: The Clinical Value of Iodine-125 Seed Implantation in the Treatment of Iodine-refractory Differentiated Thyroid Carcinoma

Status Completed

Clinical Trial Summary

A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance.

Clinical Trial Description

Data from RAIR-DTC patients hospitalized at Jiangxi Cancer Hospital from January 2015 to February 2022 were retrospectively collected.

In advance of the surgery, patients were informed about their condition, the expected efficacy of 125I seed implantation therapy, alternative treatments such as external beam radiotherapy and chemotherapy, as well as potential side effects and toxic effects. The preoperative evaluation process includes assessments of coagulation function, liver and kidney function, cardiopulmonary function, and local CT scans.

A collaborative effort between physicians and physicists was undertaken to establish a treatment regimen with a prescription dose ranging from 80 to 120 Gy. The patient accepted the treatment plan and signed an informed consent form. The CT-guided 125I seed implantation procedure was conducted according to the prescribed treatment regimen. Efficacy evaluations were conducted at pre-surgery, 1-, 3-, and 5-month post-surgery. The evaluations focused on lesion dimensions, serum thyroglobulin (Tg), TG antibodies (TGAb), thyroid-stimulating hormone (TSH) levels, pain levels, and adverse reactions.

Lesion size was determined using CT imaging. Lymph nodes were assessed based on their shortest diameter, while other target lesions were evaluated based on their longest diameter. Each measurable lesion underwent an average measurement derived from a minimum of three readings, with all measurements conducted by the same individual to minimize measurement discrepancies.

Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [1] were used to assess treatment response. Use the Visual Analogue Scale to record patients' pain scores. Postoperative adverse reactions, including infection, bleeding, pneumothorax, bone marrow suppression, and seed displacement, were recorded. Radiation injury was graded according to the Radiation Therapy Oncology Group (RTOG) and European Organization for Research and Treatment of Cancer (EORTC) toxicity criteria [2].

The data were analyzed using IBM SPSS 26.0. The count data (n%) and skewed measures [Md (Q1, Q3)] are presented. Group comparisons were conducted using the paired Wilcoxon rank-sum test, with statistical significance set at P < 0.05.

This study was approved by the Ethics Committee of Jiangxi Provincial Cancer Hospital. ;

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

• NCT number: NCT06362772
• Study type: Observational
• Source: Jiangxi Provincial Cancer Hospital
• Status: Completed
• Start date: January 1, 2015
• Completion date: April 1, 2023