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

Mucosal Melanoma Clinical Trial

— SNMM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009446
• Other study ID #: SNMM-SA-RTNeo
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 10, 2021
• Est. completion date: August 10, 2025

Study information

• Verified date: August 2021
• Source: Eye & ENT Hospital of Fudan University
• Contact: Xiaole Song, MD
• Phone: 15821388769
• Email: jxfxsxl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: August 10, 2025
• Est. primary completion date: August 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Mucosal Melanoma

Intervention

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.

Locations

Country	Name	City	State
China	Eye& ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ORR	objective remission rate	From date of first treatment to the date of best overall response before surgery, assessed up to 6 months