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A Single-Arm Study on the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adult Nasal and Paranasal Sinus Rhabdomyosarcoma
Sponsor: Eye & ENT Hospital of Fudan University
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.
Official title: A Single-Arm Clinical Study Evaluating the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adults With Nasal and Paranasal Sinus Rhabdomyosarcoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
43
Start Date
2025-10-30
Completion Date
2030-12-30
Last Updated
2026-03-04
Healthy Volunteers
Not specified
Interventions
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; 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.
Locations (1)
EENT hospital of Fudan University
Shanghai, China, China