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

Early Phase 1UnknownNCT05009446

Eye & ENT Hospital of Fudan University28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mucosal Melanoma Sinonasal Melanoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall survival

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 Outcomes

Progression-free survival

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

Local progression free survival

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

Regional progression free survival

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

Distant metastasis free survival

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

ORR

objective remission rate

Time frame: From date of first treatment to the date of best overall response before surgery, assessed up to 6 months