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NCT Number: NCT07449949

A Single-Arm Study on the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adult 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.

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Key information

Conditions

ORR OS PFS

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EENT hospital of Fudan University

Shanghai, China, 200000

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: drug, Surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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