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

Desmoid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06195085
• Other study ID #: RID
• Status: Completed
• Start date: July 1, 2013
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2021
• Gender: All
• Age group: 13 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachytherapy
• Desmoid Tumor

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	First Affiliated Hospital of the Army Medical University, Shengli Oilfield Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control time (LCT)	LCT was defined as the time from seed implantation to local progression	8 years
Primary	objective response rate (ORR)	ORR was calculated from patients achieving CR and PR	6 months
Primary	disease control rate (DCR)	DCR was likewise calculated from the patients of CR, PR and SD.	6 months
Secondary	overall survival (OS)	OS was defined as the time from RISI to death from any cause	8 years
Secondary	adverse events (AEs)	The AEs were evaluated as per Radiation Therapy Oncology Group (RTOG) guidelines.	8 years
Secondary	symptom relief rate	symptom relief rate was calculated from the patients achieving relief after treatment.	8 years