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

NCT05614375 | Recruiting

• 1 other identifier: SNSTS-SA-01-V1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma,Soft Tissue; Nasal Cavity Cancer; Paranasal Sinus Cancer; Surgery

Keywords

soft tissue sarcoma; nasal cavity and paranasal sinus; endoscopic surgery; prognose; overall survival rate; outcome; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Local recurrence-free survival

  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

  within 1 year after surgery

Study Arms (1)

soft tissue sarcoma with endoscopic surgery

patients with soft tissue sarcoma accept endoscopic surgery

Procedure: endoscopic surgery

Interventions

endoscopic surgery PROCEDURE

transnasal endoscopic surgery

soft tissue sarcoma with endoscopic surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Yu Hongmeng

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor，para-carcinoma tissue，venous blood

MeSH Terms

Conditions

Sarcoma; Paranasal Sinus Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Nose Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: November 14, 2022
• Study Start: June 12, 2021
• Primary Completion: June 12, 2023
• Study Completion (Estimated): June 12, 2026
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CN (1)