Clinical trial NCT06195085: CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors
Official title: Long-term Outcomes of CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachytherapy
Desmoid Tumor
Radioactive Iodine-125 Seed Implantation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of the Army Medical University
name: Shengli Oilfield Hospital
First posted: 2024-01-08
Enrollment: 38
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local control time (LCT)
timeFrame: 8 years
measure: objective response rate (ORR)
timeFrame: 6 months
measure: disease control rate (DCR)
timeFrame: 6 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 8 years
measure: adverse events (AEs)
timeFrame: 8 years
measure: symptom relief rate
timeFrame: 8 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Junjie Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: