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Clinical Trial Summary

This phase II trial studies how well docetaxel, cisplatin and fluorouracil work in treating patients with previously untreated stage II-IV nasal cavity and/or paranasal sinus cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF). II. To improve local tumor control to 80% at 2 years. SECONDARY OBJECTIVES I. Disease specific-survival and overall survival rates. II. Organ preservation (orbital, maxillary, cranial) rate. III. Patterns of treatment failure (local, regional, and distant). IV. Acute and late treatment-related toxicity. V. The effect of treatment on Quality of Life with and without surgery (i.e., M. D. Anderson Symptom Inventory [MDASI], M. D. Anderson Dysphagia Inventory [MDADI], Xerostomia Questionnaire, Performance Status Scale for Head & Neck Cancer Patients [PSS-HN], etc.). VI. To evaluate the effects of induction chemotherapy on biological markers that could serve as surrogates for response and predictors of long-term outcome. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive docetaxel intravenously (IV) over 1 hour on day 1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV continuously on days 1-4. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) or partial response (PR) receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have stable disease (SD) or progressive disease (PD) to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 1 year and every 6 months for 2 years. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Locally Advanced Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
  • Nasal Cavity and Paranasal Sinus Poorly Differentiated Carcinoma
  • Paranasal Sinus Neoplasms
  • Sinonasal Undifferentiated Carcinoma
  • Stage II Nasal Cavity and Paranasal Sinus Cancer AJCC v8
  • Stage III Nasal Cavity and Paranasal Sinus Cancer AJCC v8
  • Stage IVA Nasal Cavity and Paranasal Sinus Cancer AJCC v8
  • Stage IVB Nasal Cavity and Paranasal Sinus Cancer AJCC v8

NCT number NCT00707473
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 16, 2008
Completion date September 30, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05925491 - Pembrolizumab in Locally Advanced Sinonasal Carcinoma Phase 2
Active, not recruiting NCT01586767 - Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy N/A