NCT05009446

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

A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	endoscopic surgery	endoscopic surgery or endoscope-assisted surgery open surgery
RADIATION	intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy	radiotherapy was administrated before surgery
DRUG	Chemotherapy drug	Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.

Timeline

• Start date: 2021-08-10
• Primary completion: 2025-08-10
• Completion: 2025-08-10
• First posted: 2021-08-17
• Last updated: 2021-08-17

Locations

1 site across 1 country: China