Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus

November 7, 2022 updated by: Eye & ENT Hospital of Fudan University

Prospective Observational Single Arm Study of Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus

Soft tissue sarcoma (STS) refers to a group of malignant tumors derived from non-epithelial extraosseous tissues, mainly from the mesoderm, partly from the neuroectoderm, including muscle, fat, fibrous tissue, blood vessels and peripheral nerves . STS is divided into 12 major categories based on tissue origin. According to different morphologies and biological behaviors, there are more than 50 subtypes. The most common subtypes include: undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma ( SS). The most common soft tissue sarcoma in children and adolescents is rhabdomyosarcoma (RMS). Soft tissue sarcoma is a group of highly heterogeneous tumors, which are characterized by local invasiveness, invasive or destructive growth, local recurrence and distant metastasis.

The pathological features of STS that occur in the nasal cavity and sinuses are similar to other parts of the body. However, because it can affect important structures such as the orbit, optic nerve, skull base bone, dura mater, cranial nerve and even brain tissue, the diseased site is deep, the anatomical structure is complex, the treatment is difficult, the range of surgical resection is limited, and the surgical margin Negative is difficult to guarantee, and related treatments may have obvious complications, which affect the survival and prognosis of patients.

Surgical treatment is the most important and most likely effective treatment for STS. With the development of endoscopic skull base anatomy and surgical techniques, the safety and effectiveness of endoscopic sinus surgery for the treatment of nasal cavity and sinus tumors have been fully confirmed, and it has become the main surgical method for nasal cavity and sinus STS. This is also the theoretical and practical basis for the feasibility of this research.

The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.This study is divided into a screening period, a treatment period, and a follow-up period. All subjects need to sign an informed consent form before screening, perform relevant blood tests, imaging examinations, and compare the inclusion and exclusion criteria to select suitable patients to enter the treatment period. The follow-up period is 5 years.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Yu Hongmeng
        • Contact:
        • Contact:
          • Kai Xue, doctor

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For patients diagnosed with STS in the nasal cavity and paranasal sinuses through pathology, appropriate subjects will be selected according to the selection criteria and exclusion criteria of the protocol design.

Description

Inclusion Criteria:

  1. Sign the informed consent form;
  2. STS of nasal cavity and paranasal sinuses diagnosed pathologically;
  3. General physical condition can tolerate endoscopic sinus surgery;
  4. There is no distant transfer;
  5. The research team must believe that the patient can be completely removed by surgery;
  6. Good organ function;

Exclusion Criteria:

  1. The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction;
  2. Suffer from uncontrolled concurrent diseases;
  3. There is a serious neurological or mental illness, including dementia and epileptic seizures;
  4. Uncontrolled active infection;
  5. There are any other circumstances that may hinder the compliance of the research;
  6. Women who are pregnant or breastfeeding.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
soft tissue sarcoma with endoscopic surgery
patients with soft tissue sarcoma accept endoscopic surgery
Procedure: endoscopic surgery
transnasal endoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From date of enrollment until the date of death from any cause, whichever came first，through study completion,up to 5 years.
From the day of enrollment to death for any reason
From date of enrollment until the date of death from any cause, whichever came first，through study completion,up to 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence-free survival
Time Frame: From date of first treatment until the date of local recurrence or the date of death from any cause,through study completion,up to 5 years.
The time from enrollment to local recurrence or death for any reason
From date of first treatment until the date of local recurrence or the date of death from any cause,through study completion,up to 5 years.
quality of life
Time Frame: within 1 year after surgery
The Chinese version of EORTC QLQ C30 questionnaire (V3.0)
within 1 year after surgery

Collaborators and Investigators

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

Sponsor

Eye & ENT Hospital of Fudan University

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)

June 12, 2021

Primary Completion (Anticipated)

June 12, 2023

Study Completion (Anticipated)

June 12, 2026

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNSTS-SA-01-V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

undecided

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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