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Completed

NCT Number: NCT06195085

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.

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Key information

Age range

13 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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

Treatment and study plan

CT-guided radioactive iodine-125 seed implantation

Radiation

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.

Primary outcomes

  1. Local control time (LCT)

    Time frame: 8 years

    LCT was defined as the time from seed implantation to local progression

  2. objective response rate (ORR)

    Time frame: 6 months

    ORR was calculated from patients achieving CR and PR

  3. disease control rate (DCR)

    Time frame: 6 months

    DCR was likewise calculated from the patients of CR, PR and SD.

Secondary outcomes

  1. overall survival (OS)

    Time frame: 8 years

    OS was defined as the time from RISI to death from any cause

  2. adverse events (AEs)

    Time frame: 8 years

    The AEs were evaluated as per Radiation Therapy Oncology Group (RTOG) guidelines.

  3. symptom relief rate

    Time frame: 8 years

    symptom relief rate was calculated from the patients achieving relief after treatment.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
  • Shengli Oilfield Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2023
First posted
Jan 8, 2024
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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