CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors

Completed

• Conditions: Brachytherapy; Desmoid Tumor; Radioactive Iodine-125 Seed Implantation
• Interventions: Radiation: CT-guided radioactive iodine-125 seed implantation

• Registration Number: NCT06195085
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This study aimed to explore the long-term outcomes of CT-guided radioactive iodine-125 (I-125) seed implantation (RISI) for recurrent desmoid tumor.

A multicenter retrospective study reviewed 38 recurrent desmoid tumor patients receiving RISI from July 2013 to July 2021.The clinical outcomes including overall response rate (ORR), disease control rate (DCR), local control time (LCT), overall survival (OS), adverse events (AEs), and symptom relief rate were statistically assessed.

Detailed Description

Desmoid tumor was characterized by a high potential of recurrence even following initial definitive treatment. There were considerable controversies regarding the management of recurrent desmoid tumor. This study aimed to explore the long-term outcomes of CT-guided radioactive iodine-125 (I-125) seed implantation (RISI) for recurrent desmoid tumor.

38 patients, diagnosed with recurrent desmoid tumor, undergoing RISI in 3 different centers including Peking University Third Hospital, First Affiliated Hospital of the Army Medical University, and Shengli Oilfield Central Hospital from July 2013 to July 2021 were reviewed consecutively.

The clinical outcomes including overall response rate (ORR), disease control rate (DCR), local control time (LCT), overall survival (OS), adverse events (AEs), and symptom relief rate were statistically assessed.

Study Timeline

• Study Start: 2013-07-01
• Primary Completion: 2021-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. recurrent desmoid tumor confirmed by pathologic or imaging diagnosis; 2) disease size ≥1 cm and ≤ 10 cm; 3) medically inoperable or individual refusal to resection; 4) Karnofsky performance status (KPS) ≥ 60; 5) adequate hematological reserves, hepatic function, renal function and heart function; 7) expected survival > 3 months.

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Exclusion Criteria

1. unconfirmed mass; 2) tumor invading the skin or mucous membrane; 2) patients with severe bleeding tendency; 3) patients with active infectious disease, trauma and severe wounds; 4) patients with any mental disorder; 5) patients with other somatic comorbidities of clinical concern; 6) pregnancy and lactation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CT-guided radioactive iodine-125 seed implantation	CT-guided radioactive iodine-125 seed implantation	The patients, diagnosed with recurrent desmoid tumor, undergoing CT-guided radioactive iodine-125 seed implantation in 3 different centers including Peking University Third Hospital, First Affiliated Hospital of the Army Medical University, and Shengli Oilfield Central Hospital from July 2013 to July 2021.

Primary Outcome Measures

Name	Time	Method
Local control time (LCT)	8 years	LCT was defined as the time from seed implantation to local progression
disease control rate (DCR)	6 months	DCR was likewise calculated from the patients of CR, PR and SD.
objective response rate (ORR)	6 months	ORR was calculated from patients achieving CR and PR

Secondary Outcome Measures

Name	Time	Method
adverse events (AEs)	8 years	The AEs were evaluated as per Radiation Therapy Oncology Group (RTOG) guidelines.
symptom relief rate	8 years	symptom relief rate was calculated from the patients achieving relief after treatment.
overall survival (OS)	8 years	OS was defined as the time from RISI to death from any cause

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China