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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614375
• Other study ID #: SNSTS-SA-01-V1
• Status: Recruiting
• Start date: June 12, 2021
• Est. completion date: June 12, 2026

Study information

• Verified date: November 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 12, 2026
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Cavity Cancer
• Paranasal Sinus Cancer
• Paranasal Sinus Neoplasms
• Sarcoma
• Sarcoma,Soft Tissue
• Surgery

Intervention

Procedure:
• endoscopic surgery
transnasal endoscopic surgery

Locations

Country	Name	City	State
China	Yu Hongmeng	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	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	Local recurrence-free survival	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.
Secondary	quality of life	The Chinese version of EORTC QLQ C30 questionnaire (V3.0)	within 1 year after surgery