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

Early Phase 1

Recruiting

• Conditions: Sinonasal Melanoma; Mucosal Melanoma
• Interventions: Procedure: endoscopic surgery; Radiation: intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy; Drug: Chemotherapy drug

• Registration Number: NCT05009446
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-18
• Status Verified: 2021-08
• Study Start: 2021-08-10
• Study First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17
• Primary Completion: 2025-08-10
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative radiotherapy and chemotherapy	endoscopic surgery	Preoperative radiotherapy and chemotherapy plus endoscopic surgery
Preoperative radiotherapy and chemotherapy	intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy	Preoperative radiotherapy and chemotherapy plus endoscopic surgery
Preoperative radiotherapy and chemotherapy	Chemotherapy drug	Preoperative radiotherapy and chemotherapy plus endoscopic surgery

Primary Outcome Measures

Name	Time	Method
Overall survival	From date of first treatment until the date of death from any cause,through study completion,up to 2 years.	2 year Overall Survival rate

Secondary Outcome Measures

Name	Time	Method
Regional progression free survival	From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years	the date of first treatment to regional failure or death
ORR	From date of first treatment to the date of best overall response before surgery, assessed up to 6 months	objective remission rate
Progression-free survival	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	the date of first treatment to the first recording of disease progression or death from any cause.
Local progression free survival	From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years	the date of first treatment to local failure or death
Distant metastasis free survival	From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years	the date of first treatment to distant metastasis or death

Trial Locations

Locations (1)

Eye& ENT Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China