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

Eye & ENT Hospital of Fudan University

Status and phase

Enrolling

Early Phase 1

Conditions

Sinonasal Melanoma

Mucosal Melanoma

Treatments

Drug: Chemotherapy drug

Procedure: endoscopic surgery

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05009446

SNMM-SA-RTNeo

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.