Clinical trial NCT05009446: Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Mucosal Melanoma
Sinonasal Melanoma
Keywords: Sinonasal mucosal melanoma
Inductive radiotherapy
chemotherapy
overall survival
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2021-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall survival
timeFrame: From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
Secondary outcomes:
measure: Progression-free survival
timeFrame: 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
measure: Local progression free survival
timeFrame: From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years
measure: Regional progression free survival
timeFrame: From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years
measure: Distant metastasis free survival
timeFrame: From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
measure: ORR
timeFrame: From date of first treatment to the date of best overall response before surgery, assessed up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye& ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Eye& ENT Hospital of Fudan University, Shanghai, China
name: Hongmeng Yu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: