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

Long-term Outcomes of CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Desmoid Tumor; Brachytherapy; Radioactive Iodine-125 Seed Implantation
• Intervention / Treatment: Radiation: CT-guided radioactive iodine-125 seed implantation

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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The 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.

Description

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Radiation: CT-guided radioactive iodine-125 seed implantation; The CT-guided radioactive iodine-125 seed implantation procedure mainly consisted of preoperative treatment planning, intraoperative seed implantation and postoperative dosimetric evaluation. All procedures were performed as per relevant guidelines and regulations.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Shengli Oilfield Central Hospital; First Affiliated Hospital of the Army Medical University
• Investigators: Principal Investigator: Junjie Wang, M.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Fibromatosis, Aggressive
• Other Study ID Numbers: RID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: Always
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No