BrachytherapyNCT06195085
CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors
An observational study of Brachytherapy and Desmoid Tumor, run by Peking University Third Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Brachytherapy, Desmoid Tumor, Radioactive Iodine-125 Seed Implantation
- What is being tested?
- CT-guided radioactive iodine-125 seed implantation
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2013to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 75 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
Read the 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.
- Being tested
- CT-guided radioactive iodine-125 seed implantation
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided radioactive iodine-125 seed implantationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: CT-guided radioactive iodine-125 seed implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control time (LCT)
LCT was defined as the time from seed implantation to local progression
Measured: 8 years
objective response rate (ORR)
ORR was calculated from patients achieving CR and PR
Measured: 6 months
disease control rate (DCR)
DCR was likewise calculated from the patients of CR, PR and SD.
Measured: 6 months
Secondary outcomes (3)
overall survival (OS)
OS was defined as the time from RISI to death from any cause
Measured: 8 years
adverse events (AEs)
The AEs were evaluated as per Radiation Therapy Oncology Group (RTOG) guidelines.
Measured: 8 years
symptom relief rate
symptom relief rate was calculated from the patients achieving relief after treatment.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jul 2013
- Primary completion1 Jul 2021
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BrachytherapyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, Shengli Oilfield Hospital
- Responsible party
- Sponsor
- Investigators
- Junjie Wang, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195085
- Sponsor's protocol ID
- RID
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors
- ClinicalTrials.gov ID
- NCT06195085
- Acronym / sponsor ID
- RID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, Shengli Oilfield Hospital
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-guided radioactive iodine-125 seed implantation | – | Radiation: CT-guided radioactive iodine-125 seed implantationThe 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. |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided radioactive iodine-125 seed implantationThe 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. | Radiation | CT-guided radioactive iodine-125 seed implantation |
Primary outcome
Local control time (LCT)
Time frame: 8 years
LCT was defined as the time from seed implantation to local progression
objective response rate (ORR)
Time frame: 6 months
ORR was calculated from patients achieving CR and PR
disease control rate (DCR)
Time frame: 6 months
DCR was likewise calculated from the patients of CR, PR and SD.
3 secondary outcomes
overall survival (OS)
Time frame: 8 years
adverse events (AEs)
Time frame: 8 years
symptom relief rate
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Wang, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachytherapy and Desmoid Tumor, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control time (LCT) (time frame: 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.