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Condition / disease
Location
Status: Not yet recruiting

Induction Chemotherapy and Tazemetostat for Locally Advanced SMARCB1-deficient Sinonasal Carcinoma

SMARCB1-deficient sinonasal carcinoma is very locally advanced malignancy at diagnosis which often precluded upfront radical resection. The investigators are now proposing a phase II single-arm study on tazemetostat in combination with docetaxel, cisplatin and 5-FU (known as TPF regimen) as preoperative therapy for locally advanced non-metastatic SMARCB1 (INI-1)-deficient sinonasal carcinoma, followed by radical resection and/or post-operative radiation therapy (with or without concurrent chemotherapy), and tazemetostat for another 6 months. It is hypothesized that addition of tazemetostat will improve objective response rate, resectability rate, orbit preservation rate after surgery, and hopefully survival outcomes with manageable safety profiles.

Participants needed: 30
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Dr. Victor H.F. LeeUpdated: Feb 28, 2023
Eligibility criteria

Males or females are >18 years of age with body weight ≥40kg at the time of prov... [+7]

Pre-existing or co-existing epithelioid sarcoma. [+15]