Treatment for locally advanced sinonasal mucosal melanoma using chemoradiotherapy and surgery

A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma

This study is testing if a combination of chemotherapy, radiation, and surgery can help people with advanced sinonasal mucosal melanoma live longer and have better control of their cancer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05009446 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of preoperative chemoradiotherapy combined with surgery for patients with locally advanced sinonasal mucosal melanoma (SNMM), a rare and aggressive cancer. The approach aims to improve overall survival rates, loco-regional control, and reduce distant metastasis. Patients eligible for the study will undergo endoscopic surgery and receive advanced radiation therapies, including intensity-modulated radiation therapy or proton therapy, along with chemotherapy. The study focuses on patients with specific tumor stages and conditions as defined by the AJCC staging system.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with pathologically confirmed sinonasal mucosal melanoma who meet specific staging criteria and have no distant metastasis.

Not a fit: Patients with evidence of distant metastasis or uncontrolled concurrent diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with locally advanced sinonasal mucosal melanoma.

How similar studies have performed: While there is limited data on sinonasal mucosal melanoma, similar approaches in treating aggressive cancers with chemoradiotherapy have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Age over 18 years old;
2. Pathologically confirmed with sinonasal mucosal melanoma;
3. Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI);
4. T4N0-1M0 according to the 8th edition American Joint Committee on Cancer (AJCC) staging system, and breaks through the natural anatomical boundaries of orbital fascia or dura mater; or 2) any Tumor stage, with retropharyngeal node metastasis. unresectable tumor after multi-disciplinary team (MDT) discussion.
5. Eastern Cooperative Oncology Group (ECOG) score between 0 to 2;
6. No distant metastasis;
7. Adequate organ function;
8. Sign the informed consent forms.

Exclusion Criteria:

1. There is evidence or suspicious of distant metastasis on clinical examination or imaging examination;
2. suffered from uncontrolled concurrent diseases that may interfere with treatment;
3. Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.);
4. With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc;
5. With and conditions that interfere with patient compliance or safety;
6. With severe mental or neurological diseases;
7. Uncontrolled active infection diseases;
8. Pregnant or breastfeeding women;
9. Patients without personal freedom or independent civil capacity;
10. Other situations that are not suitable.

Where this trial is running

Shanghai, Shanghai

• Eye& ENT Hospital, Fudan University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Hongmeng Yu, MD,PhD — Eye& ENT Hospital of Fudan University, Shanghai, China
• Study coordinator: Xiaole Song, MD

Conditions Mucosal Melanoma; Sinonasal Melanoma; Sinonasal mucosal melanoma; Inductive radiotherapy; chemotherapy; overall survival