Trial Outcomes & Findings for Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer (NCT NCT00721513)
NCT ID: NCT00721513
Last Updated: 2020-04-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
up to 2 years
Results posted on
2020-04-07
Participant Flow
Participant milestones
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 6.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsOutcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Progression-free Survival
|
54.2 months
Standard Error 0.5
|
SECONDARY outcome
Timeframe: up to 2 yearsWill be measured by CT scan /MRI of the head and neck with corroborative results of direct biopsy of any residual tumor at primary site.
Outcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Objective Response Rate
Complete response
|
5 Participants
|
|
Objective Response Rate
Partial response
|
10 Participants
|
|
Objective Response Rate
Stable disease
|
1 Participants
|
|
Objective Response Rate
Progression of disease
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsDefined as rate of complete and partial responses (at least 30% decrease in the sum of the longest diameter of target lesions), measured by CT scan or MRI of the head and neck after completion of multimodality treatment with induction TPF (Docetaxel, cisplatin and fluorouracil) chemotherapy followed by combined ERT. We will use RECIST (Response Evaluation Criteria In Solid Tumors) (Therasse et al, 2000) for evaluation of response.
Outcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Best Overall Response Rate
Complete response
|
5 Participants
|
|
Best Overall Response Rate
Partial response
|
10 Participants
|
|
Best Overall Response Rate
Progression of disease
|
4 Participants
|
|
Best Overall Response Rate
Stable disease
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsOutcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Overall Survival
|
53.6 months
Standard Error 0.5
|
SECONDARY outcome
Timeframe: up to 2 yearsOutcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Number of Participants With Distant Metastasis
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, pre-radiation therapy and post-radiation therapy, up to 2 yearsPopulation: This data was not collected on all participants.
Four subscales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". Overall quality of life is the sum of the core items of the FACT-G possible range of 0-108 points. The higher the score the better the quality life. This interval includes 0, we will conclude that there is not conclusive statistical evidence that there is an improvement or worsening. If the interval does not include 0 we can determine whether there was a significant improvement (or worsening) depending on which side of the 0 the interval is on. The total outcome index score (possible range 0-108 points) is the sum of the physical and functional well being and additional concerns categories from the FACT-G.
Outcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=16 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Pre-RT Physical Well-Being
|
15.56 Score on a scale
Interval 10.59 to 20.52
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Post-RT Physical Well-Being
|
16.42 Score on a scale
Interval 11.08 to 21.75
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Post-RT Emotional Well-Bein
|
18.93 Score on a scale
Interval 16.1 to 21.77
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline - Physical Well-Being
|
17.21 Score on a scale
Interval 13.14 to 21.25
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline - Social/Family Well-Being
|
23.66 Score on a scale
Interval 21.4 to 25.92
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline - Emotional Well-Being
|
17.00 Score on a scale
Interval 14.3 to 19.7
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline Functional Well-Being
|
17.48 Score on a scale
Interval 14.0 to 20.95
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline Total Fact-G Score
|
75.35 Score on a scale
Interval 65.84 to 84.86
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline Additional Concerns
|
23.25 Score on a scale
Interval 18.67 to 27.83
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Total Outcome Index Score - Baseline
|
57.94 Score on a scale
Interval 48.05 to 67.82
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Pre-RT Social/Family Well-Being
|
23.90 Score on a scale
Interval 21.24 to 26.56
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Pre-RT Emotional Well-Being
|
18.80 Score on a scale
Interval 15.55 to 22.05
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Pre-RT Functional Well-Being
|
15.63 Score on a scale
Interval 11.55 to 19.72
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Pre-RT Total Fact-G Score
|
72.00 Score on a scale
Interval 59.13 to 84.87
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Pre-RT Additional Concerns
|
25.44 Score on a scale
Interval 20.43 to 30.46
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Total Outcome Index Score - Pre-RT
|
55.78 Score on a scale
Interval 44.79 to 66.76
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Post-RT Social/Family Well-Being
|
23.80 Score on a scale
Interval 20.74 to 26.86
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Post-RT Functional Well-Being
|
15.92 Score on a scale
Interval 10.72 to 21.11
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Post-RT FACT-G Total Score
|
75.07 Score on a scale
Interval 60.17 to 89.97
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Post-RT Additional Concerns
|
21.28 Score on a scale
Interval 15.4 to 27.16
|
|
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
Total Outcome Index Score - Post- RT
|
50.00 Score on a scale
Interval -22.63 to 122.63
|
SECONDARY outcome
Timeframe: up to 2 yearsOutcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Number of Participants With Local-Regional Control
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, pre-radiation therapy and post-radiation therapy, up to 2 yearsPopulation: Data was not collected for all participants.
Consists of assessment of three functions (subscales): Normalcy of diet, eating in public, and understandability of speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores range from 0-100 (Full performance (100 score), moderate or severe impairment (≤ 50 score)). The higher the score, the better the ability of the patient to function.
Outcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=16 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Performance Status Scale for Head and Neck Cancer
Baseline Performance Status for Eating
|
82.50 Score on a scale
Standard Deviation 26.48
|
|
Performance Status Scale for Head and Neck Cancer
Baseline Performance Status for Speech
|
95.00 Score on a scale
Standard Deviation 10.54
|
|
Performance Status Scale for Head and Neck Cancer
Baseline Performance Status for Diet
|
84.44 Score on a scale
Standard Deviation 20.07
|
|
Performance Status Scale for Head and Neck Cancer
Pre-RT Performance Status for Eating
|
45.83 Score on a scale
Standard Deviation 51.03
|
|
Performance Status Scale for Head and Neck Cancer
Pre-RT Performance Status for Speech
|
100.00 Score on a scale
Standard Deviation 0.00
|
|
Performance Status Scale for Head and Neck Cancer
Pre-RT Performance Status for Diet
|
41.67 Score on a scale
Standard Deviation 49.16
|
|
Performance Status Scale for Head and Neck Cancer
Post-RT Performance Status for Eating
|
50.00 Score on a scale
Standard Deviation 45.64
|
|
Performance Status Scale for Head and Neck Cancer
Post-RT Performance Status for Speech
|
93.75 Score on a scale
Standard Deviation 12.50
|
|
Performance Status Scale for Head and Neck Cancer
Post-RT Performance Status for Diet
|
40.00 Score on a scale
Standard Deviation 45.46
|
SECONDARY outcome
Timeframe: Baseline, pre-radiation therapy and post-radiation therapy, up to 2 yearsPopulation: Data was not collected on all participants
The MD Anderson Dysphasia Inventory (MDADI) is a survey specifically designed to assess dysphasia. It contains 20 questions directly addressing the swallowing function and several other general questions. The questionnaire asks for participants views about their swallowing ability at baseline, pre-radiation therapy and post-radiation therapy. All questions except for E7 and F2: Strongly Agree = 1 point, Agree = 2 points, No Opinion = 3 points, Disagree = 4 points, Strongly Disagree. E7 and F2: Strongly agree = 5 points, Agree = 4 points, no opinion = 3 points, disagree = 2 points, strongly disagree = 1 point. Scores range from 20 (extremely low-functioning) to 100 (high-functioning).
Outcome measures
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=10 Participants
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
MD Anderson Dysphagia Inventory
Pre-RT Function Score
|
76.80 Score on a scale
Standard Deviation 9.96
|
|
MD Anderson Dysphagia Inventory
Baseline Global Score
|
56.00 Score on a scale
Standard Deviation 32.39
|
|
MD Anderson Dysphagia Inventory
Baseline Emotion Score
|
71.48 Score on a scale
Standard Deviation 16.68
|
|
MD Anderson Dysphagia Inventory
Baseline Function Score
|
75.56 Score on a scale
Standard Deviation 20.34
|
|
MD Anderson Dysphagia Inventory
Baseline Physical Score
|
68.00 Score on a scale
Standard Deviation 22.94
|
|
MD Anderson Dysphagia Inventory
Pre-RT Global Score
|
88.00 Score on a scale
Standard Deviation 26.83
|
|
MD Anderson Dysphagia Inventory
Pre-RT Emotion Score
|
83.07 Score on a scale
Standard Deviation 6.35
|
|
MD Anderson Dysphagia Inventory
Pre-RT Physical Score
|
86.00 Score on a scale
Standard Deviation 19.89
|
|
MD Anderson Dysphagia Inventory
Post-RT Global Score
|
62.50 Score on a scale
Standard Deviation 36.15
|
|
MD Anderson Dysphagia Inventory
Post-RT Emotion Score
|
67.08 Score on a scale
Standard Deviation 17.59
|
|
MD Anderson Dysphagia Inventory
Post-RT Function Score
|
58.29 Score on a scale
Standard Deviation 26.62
|
|
MD Anderson Dysphagia Inventory
Post-RT Physical Score
|
67.81 Score on a scale
Standard Deviation 26.47
|
Adverse Events
TPFChemotherapy + Concomitant Cetuximab & RT
Serious events: 20 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 participants at risk
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Investigations
Low WBC
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
Investigations
low Platelets
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Low Hemoglobin
|
50.0%
10/20 • Number of events 10 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Anorexia
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
Investigations
Low ANC
|
45.0%
9/20 • Number of events 9 • Up to 2 years after completion of treatment
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Weight loss
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hyperglycemia
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
Investigations
hypocalcemia
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Investigations
hypomagnesemia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hyponatremia
|
65.0%
13/20 • Number of events 13 • Up to 2 years after completion of treatment
|
|
Investigations
hypokalemia
|
45.0%
9/20 • Number of events 9 • Up to 2 years after completion of treatment
|
|
Investigations
Bicarbonate serum-low
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hyperbilirubinemia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hypophosphatemia
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hypermagnesemia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hyperkalemia
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Dysphagia
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
General disorders
Fever without neutropenia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Hypoxia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Dehydration
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Abdomen
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Acidosis
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Back
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Colitis
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Death not associated with any term
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Lymphopenia
|
85.0%
17/20 • Number of events 17 • Up to 2 years after completion of treatment
|
|
General disorders
Pain Oral cavity
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation: Chemoradiation
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Dental problems
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Pleura
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Tumor pain
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
Other adverse events
| Measure |
TPFChemotherapy + Concomitant Cetuximab & RT
n=20 participants at risk
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
cetuximab
cisplatin
docetaxel
fluorouracil
computed tomography
positron emission tomography
quality-of-life assessment
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
|
|---|---|
|
Investigations
Low WBC
|
50.0%
10/20 • Number of events 10 • Up to 2 years after completion of treatment
|
|
Investigations
low Platelets
|
70.0%
14/20 • Number of events 14 • Up to 2 years after completion of treatment
|
|
Investigations
Low Hemoglobin
|
50.0%
10/20 • Number of events 10 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
Nausea
|
90.0%
18/20 • Number of events 18 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
15/20 • Number of events 15 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
65.0%
13/20 • Number of events 13 • Up to 2 years after completion of treatment
|
|
General disorders
Anorexia
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
General disorders
Gastrointestinal - Other
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Alkaline phosphatase
|
45.0%
9/20 • Number of events 9 • Up to 2 years after completion of treatment
|
|
Investigations
Creatinine
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
Investigations
Proteinuria
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
General disorders
Hypertension
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Cardiac disorders
Hypotension
|
40.0%
8/20 • Number of events 8 • Up to 2 years after completion of treatment
|
|
Cardiac disorders
Neuropathy: sensory
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Nervous system disorders
Neuropathy: motor
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Low ANC
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Pain
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Dizziness
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
General disorders
Taste alteration
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
General disorders
Insomnia
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Rigors/chills
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
General disorders
Sweating
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Fatigue
|
80.0%
16/20 • Number of events 16 • Up to 2 years after completion of treatment
|
|
General disorders
Weight loss
|
40.0%
8/20 • Number of events 8 • Up to 2 years after completion of treatment
|
|
Investigations
hyperglycemia
|
85.0%
17/20 • Number of events 17 • Up to 2 years after completion of treatment
|
|
Investigations
hypoglycemia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hypercalcemia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
hypocalcemia
|
90.0%
18/20 • Number of events 18 • Up to 2 years after completion of treatment
|
|
Investigations
hypomagnesemia
|
80.0%
16/20 • Number of events 16 • Up to 2 years after completion of treatment
|
|
Investigations
hyponatremia
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
Investigations
hypokalemia
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Investigations
Bicarbonate serum-low
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Investigations
hypoalbuminemia
|
90.0%
18/20 • Number of events 18 • Up to 2 years after completion of treatment
|
|
Investigations
hyperbilirubinemia
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Investigations
serum glutamic pyruvic transaminase
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
Investigations
hypophosphatemia
|
45.0%
9/20 • Number of events 10 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
Constipation
|
75.0%
15/20 • Number of events 15 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Head/headache
|
45.0%
9/20 • Number of events 9 • Up to 2 years after completion of treatment
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
Investigations
hypermagnesemia
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
Investigations
hyperkalemia
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Vascular disorders
Phlebitis
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Eye disorders
Ocular/Visual - Other
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Dysphagia
|
65.0%
13/20 • Number of events 13 • Up to 2 years after completion of treatment
|
|
General disorders
Fever without neutropenia
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
General disorders
Urinary frequency/urgency
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection - Other
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
Vascular disorders
Edema: head and neck
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
Vascular disorders
Edema: limb
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
Vascular disorders
Edema: viscera
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Heartburn/dyspepsia
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
General disorders
Dry mouth
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
General disorders
Dehydration
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
General disorders
Confusion
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pruritus/itching
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Anxiety
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
General disorders
Depression
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
10/20 • Number of events 10 • Up to 2 years after completion of treatment
|
|
General disorders
Distension bloating, abdominal
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Abdomen
|
40.0%
8/20 • Number of events 9 • Up to 2 years after completion of treatment
|
|
Investigations
Acidosis
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
Investigations
Partial Thromboplastin Time
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Joint
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Back
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Bone
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Chest/thorax
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Chest wall
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Colitis infectious
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Nervous system disorders
Seizure
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Wound complication, non-infectious
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
20.0%
4/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
Vascular disorders
Hemorrhage respiratory
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Extrapyramidal/involuntary movement/restlessness
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
General disorders
Flushing
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Investigations
gamma-Glutamyl transpeptidase
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Oral-gums
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Investigations
Glomerular filtration rate
|
25.0%
5/20 • Number of events 5 • Up to 2 years after completion of treatment
|
|
Investigations
Cholesterol, serum-high
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Investigations
hypertriglyceridemia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Gastrointestinal disorders
functional obstruction of bowel
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Kidney
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Voice changes
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Investigations
Lymphopenia
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Memory impairment
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Muscle weakness
|
35.0%
7/20 • Number of events 7 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Muscle
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Nail changes
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Mucosa
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Neck
|
35.0%
7/20 • Number of events 8 • Up to 2 years after completion of treatment
|
|
Infections and infestations
infection associated with Lymphopenia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain Oral cavity
|
25.0%
5/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Extremity-limb
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Pain: Skin
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Throat/pharynx/larynx
|
50.0%
10/20 • Number of events 10 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Pleura
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation: Chemoradiation
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Allergic rhinitis
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Salivary gland changes/saliva
|
30.0%
6/20 • Number of events 6 • Up to 2 years after completion of treatment
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus bradycardia
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
55.0%
11/20 • Number of events 11 • Up to 2 years after completion of treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
15.0%
3/20 • Number of events 3 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Dental/teeth/peridontal
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Neuropathy: cranial: CN V Motor-jaw muscles; Sensory-facial
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Trismus (difficulty, restriction or pain when opening mouth)
|
20.0%
4/20 • Number of events 4 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Urethra
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Eye disorders
blurred vision
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Vascular disorders
Hemorrhage GU: Urinary
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Cytokine release syndrome/acute infusion reaction
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Anus
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: Tumor pain
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Foreign body
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Vascular disorders
Hemorrhage pulmonary/upper respiratory
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Fibrosis-deep connective tissue
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
Ear and labyrinth disorders
Neuropathy: cranial: CN VIII Hearing and balance
|
10.0%
2/20 • Number of events 2 • Up to 2 years after completion of treatment
|
|
General disorders
Pain: External ear
|
5.0%
1/20 • Number of events 1 • Up to 2 years after completion of treatment
|
Additional Information
Dr. Mercedes Porosnicu
Wake Forest University Health Sciences
Phone: 336-716-8664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place