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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06362772
• Other study ID #: MR-36-24-010944
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2024
• Source: Jiangxi Provincial Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 1, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: Differentiated Thyroid Cancer (DTC) was confirmed by pathology, with local recurrence or distant metastasis of residual thyroid cancer and conforming to any of the following Iodine-Refractory Differentiated Thyroid Cancer (RAIR-DTC) criteria: (1) no uptake of 131I in the initial 131I treatment; (2) loss of iodine uptake capacity in previously functional iodine-avid lesions; (3) disease progression after 131I therapy, including gradual enlargement of the lesion and continuously increasing levels of serum thyroglobulin (Tg).

Exclusion Criteria: Patients with severe physical diseases, such as severe dysfunction of the cardiac, pulmonary, hepatic, or renal systems, poor compliance, inability to tolerate 125I seed implantation, severe acute infectious or chronic infection with acute exacerbation, severe coagulopathy that may lead to serious complications like infection or bleeding, pregnant or lactating women affecting fetal and infant growth and development, patients with cachexia or expected survival of =3 Months and patients with positive serum anti-thyroglobulin antibodies (TgAb) that may impact the assessment of treatment efficacy.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Radiation:
• Iodine-125 brachytherapy
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 Tg, TGAb, TSH levels, pain levels, and adverse reactions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital

References & Publications (2)

Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available. — View Citation

Watanabe H, Okada M, Kaji Y, Satouchi M, Sato Y, Yamabe Y, Onaya H, Endo M, Sone M, Arai Y. [New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1)]. Gan To Kagaku Ryoho. 2009 Dec;36(13):2495-501. Japanese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor size	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) were used to assess treatment response[1].	Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.
Primary	Serological assessment	Including serum thyroglobulin (Tg) and serum anti-thyroglobulin antibody levels (TgAb) in thyrotropin-inhibited states, as well as tumor markers such as CEA.	Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.
Primary	Pain score	Use the Visual Analogue Scale to record patients' pain scores. The scale ranges from 0 to 10 points, with pain increasing incrementally. 0 indicates no pain, 1-3 indicate mild pain that is still tolerable and does not interfere with sleep or normal life, 4-6 indicate moderate pain that interferes with sleep and requires analgesic medication to alleviate it, and 7-10 show intense and intolerable pain that seriously interferes with sleep and diet and requires strong analgesic drugs.	Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.
Primary	Adverse event	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].	Assess within six months after surgery.