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

Primary Purpose

Mucosal Melanoma, Sinonasal Melanoma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
endoscopic surgery
intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy
Chemotherapy drug
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucosal Melanoma focused on measuring Sinonasal mucosal melanoma, Inductive radiotherapy, chemotherapy, overall survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eye& ENT Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative radiotherapy and chemotherapy

Arm Description

Preoperative radiotherapy and chemotherapy plus endoscopic surgery

Outcomes

Primary Outcome Measures

Overall survival
2 year Overall Survival rate

Secondary Outcome Measures

Progression-free survival
the date of first treatment to the first recording of disease progression or death from any cause.
Local progression free survival
the date of first treatment to local failure or death
Regional progression free survival
the date of first treatment to regional failure or death
Distant metastasis free survival
the date of first treatment to distant metastasis or death
ORR
objective remission rate

Full Information

First Posted
July 18, 2021
Last Updated
August 16, 2021
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05009446
Brief Title
Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM
Acronym
SNMM
Official Title
A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Anticipated)
Primary Completion Date
August 10, 2025 (Anticipated)
Study Completion Date
August 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucosal Melanoma, Sinonasal Melanoma
Keywords
Sinonasal mucosal melanoma, Inductive radiotherapy, chemotherapy, overall survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative radiotherapy and chemotherapy
Arm Type
Experimental
Arm Description
Preoperative radiotherapy and chemotherapy plus endoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
endoscopic surgery
Intervention Description
endoscopic surgery or endoscope-assisted surgery open surgery
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy
Intervention Description
radiotherapy was administrated before surgery
Intervention Type
Drug
Intervention Name(s)
Chemotherapy drug
Intervention Description
Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.
Primary Outcome Measure Information:
Title
Overall survival
Description
2 year Overall Survival rate
Time Frame
From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
the date of first treatment to the first recording of disease progression or death from any cause.
Time Frame
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
Title
Local progression free survival
Description
the date of first treatment to local failure or death
Time Frame
From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years
Title
Regional progression free survival
Description
the date of first treatment to regional failure or death
Time Frame
From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years
Title
Distant metastasis free survival
Description
the date of first treatment to distant metastasis or death
Time Frame
From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
Title
ORR
Description
objective remission rate
Time Frame
From date of first treatment to the date of best overall response before surgery, assessed up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaole Song, MD
Phone
15821388769
Email
jxfxsxl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongmeng Yu, MD,PhD
Organizational Affiliation
Eye& ENT Hospital of Fudan University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye& ENT Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifang Wang
Phone
13916229507
First Name & Middle Initial & Last Name & Degree
Xiaoshen Wang, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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