Trial Outcomes & Findings for Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer (NCT NCT00707473)

NCT ID: NCT00707473

Last Updated: 2026-07-17

Results Overview

Overall Survival

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

5 years

Results posted on

2026-07-17

Participant Flow

Squamous cell or poorly differentiated carcinoma of nasal cavity or paranasal sinuses Stage II+, no mets, ECOG of 1+, no previous chemo- or radiotherapy

Participant milestones

Participant milestones
Measure	Overall Study All participants
Overall Study STARTED	31
Overall Study Completed 2+ Rounds of Docetaxel, Cisplatin, and Fluorouracil	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study All participants
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=28 Participants All participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Region of Enrollment United States	28 participants n=20 Participants
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=20 Participants
Age, Categorical >=65 years	9 Participants n=20 Participants
Age, Continuous	61.2 years STANDARD_DEVIATION 8.5 • n=20 Participants
Sex: Female, Male Female	7 Participants n=20 Participants
Sex: Female, Male Male	21 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=20 Participants
Race (NIH/OMB) Asian	3 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	4 Participants n=20 Participants
Race (NIH/OMB) White	17 Participants n=20 Participants
Race (NIH/OMB) More than one race	3 Participants n=20 Participants

PRIMARY outcome

Timeframe: 5 years

Overall Survival

Outcome measures

Outcome measures
Measure	Overall Study n=28 Participants All participants
Survival Alive	14 Participants
Survival Dead	14 Participants

SECONDARY outcome

Timeframe: 5 years

Patients Who Did Not Die of Disease

Outcome measures

Outcome measures
Measure	Overall Study n=28 Participants All participants
Disease-Specific Survival Not Dead of Disease	16 Participants
Disease-Specific Survival Dead of Disease	12 Participants

Adverse Events

Overall Study

Serious events: 17 serious events

Other events: 28 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Overall Study n=28 participants at risk All participants
Gastrointestinal disorders Abdominal pain	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Renal and urinary disorders Acute kidney injury	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Anorexia	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Dehydration	10.7% 3/28 • Number of events 3 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Diarrhea	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Dysgeusia	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Blood and lymphatic system disorders Febrile neutropenia	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
General disorders Fever	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Renal and urinary disorders Hyperkalemia	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Renal and urinary disorders Hypokalemia	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Renal and urinary disorders Hypomagnesemia	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Hyponatremia	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Hypotension	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Infections and infestations Muosal infection	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Musositis, oral	25.0% 7/28 • Number of events 7 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Nausea	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Blood and lymphatic system disorders Neutropenia	10.7% 3/28 • Number of events 3 • 5 Years from Protocol Consent Default
Respiratory, thoracic and mediastinal disorders Non-cardiac chest pain	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Nervous system disorders Pain	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Nervous system disorders Peripheral motor neuropathy	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Vomiting	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Blood and lymphatic system disorders White blood cells decreased	10.7% 3/28 • Number of events 3 • 5 Years from Protocol Consent Default
Nervous system disorders Syncope	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Nervous system disorders Tinnitus	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default
Renal and urinary disorders Urinary retention	3.6% 1/28 • Number of events 1 • 5 Years from Protocol Consent Default

Other adverse events

Other adverse events
Measure	Overall Study n=28 participants at risk All participants
Skin and subcutaneous tissue disorders Rash, macro-papular	17.9% 5/28 • Number of events 5 • 5 Years from Protocol Consent Default
Nervous system disorders Peripheral sensoral neuropathy	25.0% 7/28 • Number of events 7 • 5 Years from Protocol Consent Default
Blood and lymphatic system disorders Platelet count decreased	17.9% 5/28 • Number of events 5 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Hyponatremia	17.9% 5/28 • Number of events 5 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Oral pain	17.9% 5/28 • Number of events 5 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Weight loss	39.3% 11/28 • Number of events 11 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Vomiting	21.4% 6/28 • Number of events 6 • 5 Years from Protocol Consent Default
Skin and subcutaneous tissue disorders Alopecia	35.7% 10/28 • Number of events 10 • 5 Years from Protocol Consent Default
Blood and lymphatic system disorders Anemia	42.9% 12/28 • Number of events 12 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Anorexia	28.6% 8/28 • Number of events 8 • 5 Years from Protocol Consent Default
General disorders Anxiety	7.1% 2/28 • Number of events 2 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Constipation	21.4% 6/28 • Number of events 6 • 5 Years from Protocol Consent Default
Renal and urinary disorders Creatinine increased	25.0% 7/28 • Number of events 7 • 5 Years from Protocol Consent Default
Skin and subcutaneous tissue disorders Dermatitis, radiation	17.9% 5/28 • Number of events 5 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Diarrhea	32.1% 9/28 • Number of events 9 • 5 Years from Protocol Consent Default
Nervous system disorders Dizzines	14.3% 4/28 • Number of events 4 • 5 Years from Protocol Consent Default
Skin and subcutaneous tissue disorders Dry eye	10.7% 3/28 • Number of events 3 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Dry mouth	25.0% 7/28 • Number of events 7 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Dysgeusia	46.4% 13/28 • Number of events 13 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Dysphagia	28.6% 8/28 • Number of events 8 • 5 Years from Protocol Consent Default
General disorders Fatigue	85.7% 24/28 • Number of events 24 • 5 Years from Protocol Consent Default
Metabolism and nutrition disorders Hyperglycemia	17.9% 5/28 • Number of events 5 • 5 Years from Protocol Consent Default
Renal and urinary disorders Hypomagnesemia	57.1% 16/28 • Number of events 16 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Mucositis, oral	75.0% 21/28 • Number of events 21 • 5 Years from Protocol Consent Default
Gastrointestinal disorders Nausea	57.1% 16/28 • Number of events 16 • 5 Years from Protocol Consent Default
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	10.7% 3/28 • Number of events 3 • 5 Years from Protocol Consent Default
Skin and subcutaneous tissue disorders Skin hyperpigmentation	10.7% 3/28 • Number of events 3 • 5 Years from Protocol Consent Default
Nervous system disorders Tinnitus	10.7% 3/28 • Number of events 3 • 5 Years from Protocol Consent Default
Musculoskeletal and connective tissue disorders Myalgia	14.3% 4/28 • Number of events 4 • 5 Years from Protocol Consent Default

Additional Information

Ehab Hanna

M D Anderson Cancer Center

Phone: 713-745-2672

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place