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

NCT ID: NCT05009446

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2025-08-10

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.

Conditions

Mucosal Melanoma; Sinonasal Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative radiotherapy and chemotherapy

Preoperative radiotherapy and chemotherapy plus endoscopic surgery

Group Type: EXPERIMENTAL

endoscopic surgery

Intervention Type: PROCEDURE

endoscopic surgery or endoscope-assisted surgery open surgery

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

Intervention Type: RADIATION

radiotherapy was administrated before surgery

Chemotherapy drug

Intervention Type: DRUG

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

Interventions

endoscopic surgery

endoscopic surgery or endoscope-assisted surgery open surgery

Intervention Type: PROCEDURE

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

radiotherapy was administrated before surgery

Intervention Type: RADIATION

Chemotherapy drug

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Hongmeng Yu

Principal Investigator,Head of Rhinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongmeng Yu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Eye& ENT Hospital of Fudan University, Shanghai, China

Locations

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaole Song, MD

Role: CONTACT

jxfxsxl@163.com

15821388769

Facility Contacts

Weifang Wang

Role: primary

13916229507

Other Identifiers

SNMM-SA-RTNeo

Identifier Type: -

Identifier Source: org_study_id