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

Enrolling by invitation

Conditions studied: ORR, PFS, OS

In brief

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.

Key facts

Study ID

NCT07449949

Run by

Eye & ENT Hospital of Fudan University

People needed

43

Starts

2025-10-30

Expected to finish

2030-12-30

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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