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

Study Purpose

Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment. There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported. This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05009446
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eye & ENT Hospital of Fudan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hongmeng Yu, MD,PhD
Principal Investigator Affiliation	Eye& ENT Hospital of Fudan University, Shanghai, China
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Mucosal Melanoma, Sinonasal Melanoma

Arms & Interventions

Arms

Experimental: Preoperative radiotherapy and chemotherapy

Preoperative radiotherapy and chemotherapy plus endoscopic surgery

Interventions

Procedure: - endoscopic surgery

endoscopic surgery or endoscope-assisted surgery open surgery

Radiation: - intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy

radiotherapy was administrated before surgery

Drug: - Chemotherapy drug

Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Eye& ENT Hospital, Fudan University, Shanghai, Shanghai, China

Status

Recruiting

Address

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai, 200031

Site Contact

Weifang Wang

[email protected]

13916229507

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