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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06195085
Enrollment
38
Registered
2024-01-08
Start date
2013-07-01
Completion date
2023-07-01
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachytherapy, Desmoid Tumor, Radioactive Iodine-125 Seed Implantation

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.

Interventions

RADIATIONCT-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.

Sponsors

First Affiliated Hospital of the Army Medical University
CollaboratorUNKNOWN
Shengli Oilfield Hospital
CollaboratorOTHER
Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Local control time (LCT)8 yearsLCT was defined as the time from seed implantation to local progression
objective response rate (ORR)6 monthsORR was calculated from patients achieving CR and PR
disease control rate (DCR)6 monthsDCR was likewise calculated from the patients of CR, PR and SD.

Secondary

MeasureTime frameDescription
overall survival (OS)8 yearsOS was defined as the time from RISI to death from any cause
adverse events (AEs)8 yearsThe AEs were evaluated as per Radiation Therapy Oncology Group (RTOG) guidelines.
symptom relief rate8 yearssymptom relief rate was calculated from the patients achieving relief after treatment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026