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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01810 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2007-0433 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (docetaxel, cisplatin, and fluorouracil) | Experimental | INDUCTION CHEMOTHERAPY: Patients receive docetaxel 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 CR or PR receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have SD or PD to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical/radiographic complete rate after induction chemotherapy with docetaxel, cisplatin, and fluorouracil | Up to 5 years | |
| Local tumor control to 80% | At 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease specific-survival rate | Up to 5 years | |
| Overall survival rate | Up to 5 years | |
| Organ preservation (orbital, maxillary, cranial) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehab Y Hanna | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Chemoradiotherapy | Other | Undergo chemoradiotherapy |
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| Cisplatin | Drug | Given IV |
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| Definitive Surgical Resection | Procedure | Undergo surgery |
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| Docetaxel | Drug | Given IV |
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| Fluorouracil | Drug | Given IV |
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| Quality-of-Life Assessment | Procedure | Correlative studies |
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| Radiation Therapy | Radiation | Undergo radiation therapy |
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| Up to 5 years |
| Patterns of treatment failure (local, regional, and distant) | Up to 5 years |
| Acute treatment-related toxicity | U to 5 years |
| Late treatment-related toxicity | Up to 5 years |
| Quality of Life with and without surgery | Up to 5 years |
| Biological markers | Up to 5 years |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| C537344 | Sinonasal undifferentiated carcinoma |
| D010255 | Paranasal Sinus Neoplasms |
| ID | Term |
|---|---|
| D009669 | Nose Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010254 | Paranasal Sinus Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D059248 | Chemoradiotherapy |
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| D000077143 | Docetaxel |
| D005472 | Fluorouracil |
| C029917 | dehydroftorafur |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D055585 | Physical Phenomena |
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