Trial Outcomes & Findings for Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer (NCT NCT00462735)
NCT ID: NCT00462735
Last Updated: 2018-03-13
Results Overview
Percentage of Participants with Loco-regional recurrence.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
2 years
Results posted on
2018-03-13
Participant Flow
Recruitment period January 2007 through April 2008. All cases were reviewed at a multidisciplinary conference, which was attended by representatives from the Departments of Head and Neck Surgery, Radiation Oncology, Medical Oncology, Palliative Care, Social Work, and Nutrition at Icahn School of Medicine at Mount Sinai.
Participant milestones
| Measure |
Advanced Head and Neck Cancer
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck. Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.
Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Advanced Head and Neck Cancer
n=33 Participants
Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Performance score
0
|
12 participants
n=5 Participants
|
|
Performance score
1
|
19 participants
n=5 Participants
|
|
Performance score
2
|
2 participants
n=5 Participants
|
|
Charlson comorbidity score
0-1
|
27 participants
n=5 Participants
|
|
Charlson comorbidity score
≥2
|
6 participants
n=5 Participants
|
|
Alcohol consumption
None
|
10 participants
n=5 Participants
|
|
Alcohol consumption
Occasional
|
14 participants
n=5 Participants
|
|
Alcohol consumption
Moderate
|
2 participants
n=5 Participants
|
|
Alcohol consumption
Heavy
|
7 participants
n=5 Participants
|
|
Smoking
None
|
6 participants
n=5 Participants
|
|
Smoking
Cigar, pipe, or betel nut only
|
3 participants
n=5 Participants
|
|
Smoking
≤20 pack-y
|
9 participants
n=5 Participants
|
|
Smoking
20.1-40 packk-y
|
7 participants
n=5 Participants
|
|
Smoking
>40 pack-y
|
8 participants
n=5 Participants
|
|
Primary site
Sinonasal
|
2 participants
n=5 Participants
|
|
Primary site
Nasopharynx
|
2 participants
n=5 Participants
|
|
Primary site
Oropharynx
|
14 participants
n=5 Participants
|
|
Primary site
Oral cavity
|
6 participants
n=5 Participants
|
|
Primary site
Salivary gland
|
1 participants
n=5 Participants
|
|
Primary site
Larynx
|
2 participants
n=5 Participants
|
|
Primary site
Hyopharynx
|
4 participants
n=5 Participants
|
|
Primary site
Unknown primary
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPercentage of Participants with Loco-regional recurrence.
Outcome measures
| Measure |
Advanced Head and Neck Cancer
n=33 Participants
Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
|
|---|---|
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Llocoregional Recurrence
|
27 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOverall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology
Outcome measures
| Measure |
Advanced Head and Neck Cancer
n=33 Participants
Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
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|---|---|
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Survival
Overall Survival
|
86 percentage of participants
|
|
Survival
Disease-Free Survival
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsGrade 3 toxicities events
Outcome measures
| Measure |
Advanced Head and Neck Cancer
n=33 Participants
Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
|
|---|---|
|
Long- Term Toxicity
|
32 events
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Twenty patients completed the UW-QOLR questionnaire before and after therapy.
University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).
Outcome measures
| Measure |
Advanced Head and Neck Cancer
n=20 Participants
Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
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|---|---|
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UW-QOLR: Quality of Life Score
|
80 units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of participants who did not have distant control
Outcome measures
| Measure |
Advanced Head and Neck Cancer
n=33 Participants
Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
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|---|---|
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Distant Metastases
|
21 percentage of participants
|
Adverse Events
Advanced Head and Neck Cancer
Serious events: 33 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Advanced Head and Neck Cancer
n=33 participants at risk
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
|
|---|---|
|
Gastrointestinal disorders
Mucositis
|
33.3%
11/33
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
15.2%
5/33
|
|
General disorders
Pain
|
42.4%
14/33
|
|
Blood and lymphatic system disorders
Low Absolute neutrophil count
|
12.1%
4/33
|
|
Blood and lymphatic system disorders
Low White blood count
|
18.2%
6/33
|
|
Blood and lymphatic system disorders
Low Hemoglobin count
|
18.2%
6/33
|
|
Blood and lymphatic system disorders
Low Platelets count
|
3.0%
1/33
|
Other adverse events
| Measure |
Advanced Head and Neck Cancer
n=33 participants at risk
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
|
|---|---|
|
Gastrointestinal disorders
Mucositis
|
66.7%
22/33
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
84.8%
28/33
|
|
General disorders
Pain
|
57.6%
19/33
|
|
General disorders
Xerostomia
|
100.0%
33/33
|
|
Blood and lymphatic system disorders
Low Absolute neutrophil count
|
54.5%
18/33
|
|
Blood and lymphatic system disorders
Low White blood count
|
75.8%
25/33
|
|
Blood and lymphatic system disorders
Low Hemoglobin count
|
75.8%
25/33
|
|
Blood and lymphatic system disorders
Low Platelet count
|
24.2%
8/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place