A Single-Arm Study on the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adult Nasal and Paranasal Sinus Rhabdomyosarcoma

February 27, 2026 updated by: Eye & ENT Hospital of Fudan University

A Single-Arm Clinical Study Evaluating the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adults With Nasal and Paranasal Sinus Rhabdomyosarcoma

Given the rarity of nasal and paranasal sinus rhabdomyosarcoma (SNRMS), there is a lack of literature on systemic treatment models for adult SNRMS, let alone prospective clinical studies. After referring to the literature, combining clinical practice and summarizing the previous treatment data of our center, we plan to conduct a prospective clinical trial: a study on the treatment of adult SNRMS with induction chemotherapy combined with radical chemoradiotherapy followed by adjuvant chemotherapy and surgery. The cumulative chemotherapy course is 8 (4 courses before radiotherapy and 4 courses after radiotherapy), and the total radiotherapy dose is 62-66Gy.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • China
      • Shanghai, China, China, 200000
        • EENT hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study was conducted in patients with primary pathologically confirmed as rhabdomyosarcoma of the nasal cavity and paranasal sinuses without distant metastasis(subjects must have a measurable tumor lesion at baseline).

Description

Inclusion Criteria:

  • Age: 18-70 years old, gender not limited.
  • Pathologically confirmed as rhabdomyosarcoma of the nasal cavity and paranasal sinuses.
  • First-time treatment patients.
  • Distant metastasis was ruled out through a comprehensive physical examination.
  • Cases that met the inclusion criteria after joint discussion with rhinologists.
  • Expected survival period ≥6 months.
  • ECOG score: 0-2.

Exclusion Criteria:

  • Patients whose distant metastasis has been clearly identified.
  • Previously, chemotherapy, immunotherapy or biological targeted therapy has been applied to the target lesion; Patients whose target lesions have received radiotherapy or surgery (excluding biopsy).
  • Functional impairment of vital organs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 24 weeks
Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: up to 5 year
progression free survival; It refers to the time between the start of treatment and the onset of disease progression or death from any cause
up to 5 year
OS
Time Frame: up to 5 year
It refers to the time between the start of treatment and death from any cause. Patients alive at the last follow-up will be censored.
up to 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025206-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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