By InvitationNot Applicable

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

China43 participantsStarted 2025-10-30

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

ORR

Timeframe: up to 24 weeks

Trial details

NCT IDNCT07449949

SponsorEye & ENT Hospital of Fudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-31