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

NCT05151588 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Sinonasal Carcinoma

Interventions

DRUG

Docetaxel

Docetaxel 75mg/m2 intravenous infusion on day 1 every 3 weeks for 3 cycles as induction therapy

DRUG

Cis Platinum

Cisplatin 75mg/m2 intravenous infusion on day 1 every 3 weeks for 3 cycles as induction therapy

DRUG

5-FU

5-FU 750mg/m2 intravenous infusion from day 1 to day 5 every 3 weeks for 3 cycles as induction therapy

DRUG

Tazemetostat

Tazemetostat 800mg twice per day orally in continuously for 3 cycles as induction therapy and maintenance therapy

PROCEDURE

Surgery

Radical surgery

OTHER

Chemoradiation

Chemoradiation as either radical treatment or post-operative treatment after surgery

Sponsors & Collaborators

  • Dr. Victor H.F. Lee

    lead OTHER

Principal Investigators

  • Victor Ho Fun Lee, MD · Department of Clinical Oncology, The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-08-31
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05151588 on ClinicalTrials.gov