Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Aug 16, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for a rare and aggressive type of cancer called sinonasal mucosal melanoma (SNMM). The study will explore how combining chemotherapy and radiation therapy before surgery can help improve survival and control the disease in patients with locally advanced SNMM. The goal is to see if this combination can lead to better outcomes, such as longer life and fewer recurrences of the cancer.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of sinonasal mucosal melanoma. They should have a specific stage of the disease (T4N0-1M0) and must not have any distant spread of cancer. Participants will undergo preoperative treatment and then surgery, with the hope of improving their chances of recovery. The trial is currently recruiting patients, and those who join will be closely monitored throughout the process to ensure their safety and to gather data on the treatment's effectiveness.

Gender

ALL

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.