Endoscopic surgery for soft tissue sarcoma in the nasal cavity and sinuses
Prospective Observational Single Arm Study of Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus
This study is testing if endoscopic surgery can effectively treat soft tissue sarcoma in the nasal cavity and sinuses while looking at any complications and how it works with other treatments like chemotherapy and radiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05614375 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and complications of endoscopic sinus surgery in treating soft tissue sarcoma located in the nasal cavity and paranasal sinuses. It will involve a single-arm, prospective approach where patients diagnosed with this type of cancer will undergo surgery, followed by a comprehensive assessment of their outcomes over a five-year follow-up period. The study will also explore the relationship between surgical treatment and adjunct therapies like chemotherapy and radiotherapy. Participants will be carefully screened to ensure they meet specific inclusion criteria before entering the treatment phase.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with soft tissue sarcoma of the nasal cavity and paranasal sinuses who can tolerate endoscopic surgery.
Not a fit: Patients with severe comorbidities, uncontrolled diseases, or surgical contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and overall survival rates for patients with soft tissue sarcoma in the nasal cavity and sinuses.
How similar studies have performed: While there is limited data on this specific approach, similar studies involving endoscopic surgery for other types of cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Yu Hongmeng — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.