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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mucosal Melanoma, Sinonasal Melanoma

Intervention / Treatment
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* Procedure: endoscopic surgery
* Radiation: intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy
* Drug: Chemotherapy drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old; Pathologically confirmed with sinonasal mucosal melanoma; Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI); 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. Eastern Cooperative Oncology Group (ECOG) score between 0 to 2; No distant metastasis; Adequate organ function; Sign the informed consent forms. Exclusion Criteria: There is evidence or suspicious of distant metastasis on clinical examination or imaging examination; suffered from uncontrolled concurrent diseases that may interfere with treatment; 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.); With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc; With and conditions that interfere with patient compliance or safety; With severe mental or neurological diseases; Uncontrolled active infection diseases; Pregnant or breastfeeding women; Patients without personal freedom or independent civil capacity; Other situations that are not suitable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative radiotherapy and chemotherapy<br>Preoperative radiotherapy and chemotherapy plus endoscopic surgery | Procedure: endoscopic surgery<br>* endoscopic surgery or endoscope-assisted surgery open surgery<br>Radiation: intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy<br>* radiotherapy was administrated before surgery<br>Drug: Chemotherapy drug<br>* Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 2 year Overall Survival rate | From date of first treatment until the date of death from any cause,through study completion,up to 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | the date of first treatment to the first recording of disease progression or death from any cause. | From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years | 
| Local progression free survival | the date of first treatment to local failure or death | From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years | 
| Regional progression free survival | the date of first treatment to regional failure or death | From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years | 
| Distant metastasis free survival | the date of first treatment to distant metastasis or death | From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years | 
| ORR | objective remission rate | From date of first treatment to the date of best overall response before surgery, assessed up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinonasal mucosal melanoma, Inductive radiotherapy, chemotherapy, overall survival