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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression free survival; It refers to the time between the start of treatment and the onset of disease progression or death from any cause | up to 5 year |
| OS | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EENT hospital of Fudan University | Shanghai | China | 200000 | China |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013514 | Surgical Procedures, Operative |
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| up to 5 year |