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

NCT05009446 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-08-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Hongmeng Yu, MD,PhD · Eye& ENT Hospital of Fudan University, Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2025-08-10
Completion
2025-08-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009446 on ClinicalTrials.gov