A Single-Arm Study on the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adult Nasal and Paranasal Sinus Rhabdomyosarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VMAT.
- Who it may be relevant to
- Registry conditions: ORR, PFS, OS. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-Arm Clinical Study Evaluating the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adults With Nasal and Paranasal Sinus Rhabdomyosarcoma
Overview
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.
Interventions
- Radiation VMAT
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; Admin
Primary outcome measures
- ORR [Time frame: up to 24 weeks]
Secondary outcome measures (2)
- PFS [Time frame: up to 5 year]
- OS [Time frame: up to 5 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- EENT hospital of Fudan University — Shanghai
Identifiers
NCT: NCT07449949 · 2025206-1