RISI in the Treatment of Recurrent Metastatic SCC of Thoracic Inlet Lymph Nodes

December 22, 2023 updated by: Peking University Third Hospital

Study on the Safety and Efficacy of 3D-printed Template Assisted Ct-guided RISI in the Treatment of Recurrent Metastatic Squamous Cell Carcinoma of Thoracic Inlet Lymph Nodes After Radiotherapy: a Multi-center Prospective Cohort Study

The malignant tumor at the thoracic entrance is difficult to be surgically removed, and radiotherapy or radiotherapy based comprehensive treatment is often chosen at the initial diagnosis. However, for patients with recurrence after radiotherapy, there is basically no ideal local treatment.The Radioactive i-125 Seed Implantation (RISI) therapy is characterized by high dose within the tumor target area and low dose to surrounding normal tissues, and its radiation dose rate is low, which theoretically benefits the protection of normal tissues and is more suitable for the salvage treatment of recurrent lesions after radiotherapy.3 d printing template technology is through the advance of the preoperative plan design and optimization, to achieve better avoid endanger organs, template of individualized and human body surface after laminating, registration accuracy, its guide pillar to precise control the direction of the needle, the present data show that in the template with CT guided by solid tumors as well had significantly higher accuracy, as the actual target dose of basic postoperative can reach the design request of the preoperative planning, so the application of 3 d printing template helps to further improve the operation efficiency and safety, also has potential promotion effect to curative effect.

The purpose of this study is: (1) Observe the efficacy, toxicity and side effects of 3d-printed template assisted ct-guided RISI in the treatment of recurrent metastatic squamous cell carcinoma of thoracic inlet lymph node after radiotherapy, and evaluate its safety and effectiveness; (2) to explore the relationship between the efficacy, toxicity and side effects of relapsed metastatic squamous cell carcinoma of thoracic inlet lymph node after radiotherapy with different RISI doses;(3)the related influencing factors affecting the effect/toxicity of RISI in the treatment of relapsed lymph node metastatic squamous cell carcinoma at the thoracic inlet after radiotherapy were analyzed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a non-randomized, prospective, single-arm, cohort study.Patients meeting the inclusion criteria were enrolled successively in the order of admission and treatment.In this study, the dose interval was set as 110-130gy, and a total of 30 patients were expected to be enrolled. The prescription dose was planned to be grouped into 15 patients of 110-120gy and 120-130gy respectively. The specific situation was subject to the actual postoperative verification dose.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) age 18-75 years
  • (2) the lesion was located at the thoracic entrance, pathologically diagnosed as lymph node metastatic squamous cell carcinoma, and relapsed after radiotherapy. The diameter of the lesion was ≤5cm
  • (3) no systemic metastasis or metastasis, the metastasis has been controlled by early treatment
  • (4) no bleeding tendency, anticoagulant treatment and (or) anti-platelet coagulation drugs should be at least 1 week before the seed implantation treatment
  • (5) not complicated with serious or uncontrolled basic diseases (such as serious or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, etc.)
  • (6) there is a suitable puncture path, is expected to reach the treatment dose;7 KPS> score of 70, expected to be able to tolerate puncture/particle therapy, the expected survival time is more than 3 months

Exclusion Criteria:

  • (1) extensive invasion of the lesion or surrounding of large blood vessels or large scope of liquefaction necrosis inside the lesion, high risk of expected puncture bleeding or poor particle distribution
  • (2) puncture site infection and/or ulcer
  • (3) pregnant women, nursing women, children and mental patients
  • (4) patients who are participating in other clinical studies
  • (5) poor compliance, unable to complete the treatment
  • (6) the researchers consider it inappropriate to participate in the clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I-125 Seed Implantation
All the enrolled patients were treated with ct-guided radioactive i-125 seed implantation assisted by 3D printing template.Prescription dose 110-130gy.
Radiation: 3D-printing Template-assisted CT-guided I-125 Seed Implantation
(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seed implantation;(4) intraoperative optimization;Postoperative dose verification.Dosimetric parameters include: dose D90 and D100 reaching a certain percentage target volume;Target volume V100, V150 and V200 reaching a certain percentage of prescribed dose;And the dose of organs at risk: Dmean, D2cc, d0.5cc, d0.1cc.Regular follow-up was conducted after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tumor control rate
Time Frame: 3 years
The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation.
3 years
Incidence of adverse events
Time Frame: 3 years
The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival time
Time Frame: 3 years
The time from the date of seeds implantation to the date of death from any cause or the date of last observation.
3 years
progression-free survival
Time Frame: 3 years
The time between the beginning of treatment and the progression of the disease or the occurrence of death for any reason.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Junjie Wang, M.D. Ph.D, Department of Radiation Oncology, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNRBG-2019-MST-RISI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 2 years of the study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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