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

NCT07449949 | Enrolling By Invitation

• 1 other identifier: 2025206-1
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ORR; PFS; OS

Keywords

nasal and paranasal sinus rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

• ORR

  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 Outcomes (2)

• PFS

  up to 5 year

• OS

  up to 5 year

Interventions

VMAT RADIATION

Vincristine: 1.4 mg/m², administered on the first day of each cycle. Actinomycin D: 1.5 mg/ m², intravenous injection, maximum not exceeding 2mg, administered on the first day of each cycle; Or epirubicin: 60-70 mg/m², intravenously infused for 30 minutes, administered on the first day of each cycle. Cisplatin: 25 mg/m², administered on days 1 to 3 of each cycle. Cyclophosphamide: 1-1.2 g/m², intravenously infused for 30-60 minutes, or 0.6-0.7 g/m², intravenously infused for 30-60 minutes; Administration on the first day of each cycle. Each administration cycle lasts for 3 weeks, with a total of 4+4 cycles. Local expanded field radiotherapy was performed within 2 weeks after the completion of 4 cycles of treatment, with the target area reaching a total dose of 62-66Gy. The specific dose was determined by the researcher based on the patient's specific condition. One month after completing radiotherapy, continue to complete four cycles of adjuvant chemotherapy.

Also known as: drug, Surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

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.
• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

EENT hospital of Fudan University

Shanghai, China, 200000, China

Location

MeSH Terms

Interventions

Pharmaceutical Preparations; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 30, 2030
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

CN (1)