Trial Outcomes & Findings for Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE) (NCT NCT00117572)
NCT ID: NCT00117572
Last Updated: 2018-04-09
Results Overview
Survival rates over 6 years.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
285 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2018-04-09
Participant Flow
Participant milestones
| Measure |
Induction Plus Chemoradiotherapy
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
141
|
|
Overall Study
COMPLETED
|
138
|
135
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Induction Plus Chemoradiotherapy
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Overall Study
Site withdrew before starting treatment
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
Baseline characteristics by cohort
| Measure |
Induction Plus Chemoradiotherapy
n=138 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
n=5 Participants
|
56.9 years
n=7 Participants
|
56.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsSurvival rates over 6 years.
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=138 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Overall Survival: Time From Randomization to Death From Any Cause
|
74.9 percentage of participants
Interval 67.4 to 82.4
|
72.8 percentage of participants
Interval 65.1 to 80.6
|
SECONDARY outcome
Timeframe: Up to 6 yearsDFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=138 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
|
69.3 percentage of participants
Interval 61.1 to 77.5
|
63.8 percentage of participants
Interval 55.4 to 72.2
|
SECONDARY outcome
Timeframe: Up to 6 yearsRecurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=138 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
|
68.6 percentage of participants
Interval 60.6 to 76.7
|
58.6 percentage of participants
Interval 49.9 to 67.2
|
SECONDARY outcome
Timeframe: Up to 6 yearsPercentage of patients with local/regional recurrence
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=138 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Failure Pattern (Local/Regional Recurrence)
|
10.1 percentage of participants
Interval 5.7 to 16.4
|
12.6 percentage of participants
Interval 7.5 to 19.4
|
SECONDARY outcome
Timeframe: Up to 6 yearsPercentage of patients with distant recurrence
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=138 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Failure Pattern (Distant Recurrence)
|
13.8 percentage of participants
Interval 8.5 to 20.7
|
21.5 percentage of participants
Interval 14.9 to 29.4
|
SECONDARY outcome
Timeframe: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=77 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=85 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (FACT H&N)
|
-11.41 units on a scale
Standard Error 1.11
|
-12.34 units on a scale
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=75 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=86 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (Normalcy of Diet)
|
-54.00 units on a scale
Standard Error 3.95
|
-41.51 units on a scale
Standard Error 4.30
|
SECONDARY outcome
Timeframe: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=75 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=85 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (Speech)
|
-10.67 units on a scale
Standard Error 2.77
|
-7.35 units on a scale
Standard Error 2.21
|
SECONDARY outcome
Timeframe: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=76 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=84 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (McMaster)
|
-9.72 units on a scale
Standard Error 0.90
|
-9.79 units on a scale
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Change from baseline to 1 year (1 year-pre)Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=43 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=40 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (FACT H&N)
|
-7.60 units on a scale
Standard Error 1.14
|
-7.34 units on a scale
Standard Error 1.31
|
SECONDARY outcome
Timeframe: Change from baseline to 1 year (1 year-pre)Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=46 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=45 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (Normalcy of Diet)
|
-10.22 units on a scale
Standard Error 4.49
|
-8.89 units on a scale
Standard Error 4.09
|
SECONDARY outcome
Timeframe: Change from baseline to 1 year (1 year-pre)Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=44 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=44 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (Speech)
|
-1.70 units on a scale
Standard Error 1.70
|
-3.41 units on a scale
Standard Error 1.74
|
SECONDARY outcome
Timeframe: Change from baseline to 1 year (1 year-pre)Population: Survivors who completed the questionnaire. (Patients with missing data excluded.)
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
Outcome measures
| Measure |
Induction Plus Chemoradiotherapy
n=45 Participants
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=42 Participants
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Quality of Life (McMaster)
|
-3.29 units on a scale
Standard Error 1.08
|
-6.00 units on a scale
Standard Error 1.15
|
Adverse Events
Induction Plus Chemoradiotherapy
Serious events: 65 serious events
Other events: 132 other events
Deaths: 39 deaths
Chemoradiotherapy
Serious events: 38 serious events
Other events: 129 other events
Deaths: 42 deaths
Serious adverse events
| Measure |
Induction Plus Chemoradiotherapy
n=138 participants at risk
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 participants at risk
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
2/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Psychiatric disorders
Agitation
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Nervous system disorders
Ataxia
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Infections and infestations
Bacteremia
|
3.6%
5/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Vascular disorders
Thromboembolic event
|
2.9%
4/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/138 • 6 years
|
1.5%
2/135 • 6 years
|
|
Cardiac disorders
Bradycardia
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Cardiac disorders
Cardiac stenosis
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Cellulitis
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
General disorders
Chills
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Psychiatric disorders
Confusion
|
1.4%
2/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Cardiac disorders
Heart failure
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Gastrointestinal disorders
Constipation
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
General disorders
Death NOS
|
2.2%
3/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Infections and infestations
Sepsis
|
2.2%
3/138 • 6 years
|
1.5%
2/135 • 6 years
|
|
General disorders
Decreased PO intake
|
0.00%
0/138 • 6 years
|
1.5%
2/135 • 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
12/138 • 6 years
|
3.7%
5/135 • 6 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
7/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Nervous system disorders
Dizziness
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
5/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
3/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
General disorders
Edema
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Nervous system disorders
Seizure
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.72%
1/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Blood and lymphatic system disorders
Fatal bleeding
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
6/138 • 6 years
|
1.5%
2/135 • 6 years
|
|
General disorders
Fever
|
10.1%
14/138 • 6 years
|
6.7%
9/135 • 6 years
|
|
Psychiatric disorders
Hallucinations
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
General disorders
General status alteration
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
2/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Vascular disorders
Hypotension
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
2/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Infections and infestations
Infection NOS
|
3.6%
5/138 • 6 years
|
4.4%
6/135 • 6 years
|
|
Investigations
White blood cell decreased
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Gastrointestinal disorders
Oral pain
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
7.2%
10/138 • 6 years
|
5.2%
7/135 • 6 years
|
|
Gastrointestinal disorders
Nausea
|
3.6%
5/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Investigations
Neutrophil count decreased
|
5.8%
8/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Investigations
Neutropenic fever
|
4.3%
6/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
General disorders
Pain
|
4.3%
6/138 • 6 years
|
1.5%
2/135 • 6 years
|
|
Infections and infestations
Peritoneal infection
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.2%
3/138 • 6 years
|
3.0%
4/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary MRI
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Injury, poisoning and procedural complications
Reaction to vancomycin
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumopathy
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Infections and infestations
Positive staph aureus
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Nervous system disorders
Syncope
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
General disorders
Throat pain
|
0.72%
1/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Tracheostomy placement
|
0.00%
0/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Infections and infestations
Urinary tract infection
|
0.72%
1/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
6/138 • 6 years
|
2.2%
3/135 • 6 years
|
|
General disorders
Weakness
|
1.4%
2/138 • 6 years
|
0.00%
0/135 • 6 years
|
|
Injury, poisoning and procedural complications
G-tube complications
|
1.4%
2/138 • 6 years
|
3.7%
5/135 • 6 years
|
|
Gastrointestinal disorders
G-tube placement
|
0.72%
1/138 • 6 years
|
0.74%
1/135 • 6 years
|
Other adverse events
| Measure |
Induction Plus Chemoradiotherapy
n=138 participants at risk
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatin: 75 mg/m2 on day 1
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
Chemoradiotherapy
n=135 participants at risk
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapy: See protocol for details
radiotherapy: See protocol for details
|
|---|---|---|
|
General disorders
Fatigue
|
85.5%
118/138 • 6 years
|
69.6%
94/135 • 6 years
|
|
General disorders
Fever
|
22.5%
31/138 • 6 years
|
22.2%
30/135 • 6 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.7%
63/138 • 6 years
|
25.2%
34/135 • 6 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
73.2%
101/138 • 6 years
|
82.2%
111/135 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
18.1%
25/138 • 6 years
|
10.4%
14/135 • 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
61.6%
85/138 • 6 years
|
55.6%
75/135 • 6 years
|
|
Gastrointestinal disorders
Constipation
|
37.7%
52/138 • 6 years
|
40.0%
54/135 • 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
42.8%
59/138 • 6 years
|
26.7%
36/135 • 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
44.9%
62/138 • 6 years
|
23.0%
31/135 • 6 years
|
|
Gastrointestinal disorders
Dysphagia
|
42.8%
59/138 • 6 years
|
43.7%
59/135 • 6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
78.3%
108/138 • 6 years
|
85.2%
115/135 • 6 years
|
|
Gastrointestinal disorders
Nausea
|
65.9%
91/138 • 6 years
|
53.3%
72/135 • 6 years
|
|
Gastrointestinal disorders
Vomiting
|
42.8%
59/138 • 6 years
|
29.6%
40/135 • 6 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.9%
22/138 • 6 years
|
1.5%
2/135 • 6 years
|
|
Infections and infestations
Infection NOS
|
29.0%
40/138 • 6 years
|
24.4%
33/135 • 6 years
|
|
General disorders
Edema limbs
|
10.9%
15/138 • 6 years
|
11.1%
15/135 • 6 years
|
|
Nervous system disorders
Neuropathy motor
|
8.7%
12/138 • 6 years
|
5.2%
7/135 • 6 years
|
|
Nervous system disorders
Neuropathy sensory
|
14.5%
20/138 • 6 years
|
5.9%
8/135 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
10.1%
14/138 • 6 years
|
3.7%
5/135 • 6 years
|
|
Nervous system disorders
Headache
|
8.7%
12/138 • 6 years
|
7.4%
10/135 • 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
34.8%
48/138 • 6 years
|
32.6%
44/135 • 6 years
|
|
General disorders
Pain
|
44.2%
61/138 • 6 years
|
47.4%
64/135 • 6 years
|
|
Investigations
Neutrophil count decreased
|
60.1%
83/138 • 6 years
|
26.7%
36/135 • 6 years
|
|
Investigations
Hemoglobin
|
92.0%
127/138 • 6 years
|
91.1%
123/135 • 6 years
|
|
Investigations
Platelet count decreased
|
40.6%
56/138 • 6 years
|
25.2%
34/135 • 6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
87.7%
121/138 • 6 years
|
83.7%
113/135 • 6 years
|
|
Investigations
Hypoglycemia
|
12.3%
17/138 • 6 years
|
9.6%
13/135 • 6 years
|
|
Investigations
White blood cell decreased
|
84.8%
117/138 • 6 years
|
65.9%
89/135 • 6 years
|
|
Investigations
Aspartate aminotransferase increased
|
31.2%
43/138 • 6 years
|
33.3%
45/135 • 6 years
|
|
Investigations
Alanine aminotransferase increased
|
39.9%
55/138 • 6 years
|
43.7%
59/135 • 6 years
|
|
Investigations
Alkaline phosphatase increased
|
43.5%
60/138 • 6 years
|
20.0%
27/135 • 6 years
|
|
Investigations
Blood bilirubin increased
|
13.8%
19/138 • 6 years
|
8.9%
12/135 • 6 years
|
|
Investigations
Creatinine increased
|
26.8%
37/138 • 6 years
|
11.9%
16/135 • 6 years
|
|
Psychiatric disorders
Anxiety
|
8.7%
12/138 • 6 years
|
8.9%
12/135 • 6 years
|
|
Infections and infestations
Candidiasis
|
9.4%
13/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
10/138 • 6 years
|
10.4%
14/135 • 6 years
|
|
Psychiatric disorders
Depression
|
10.9%
15/138 • 6 years
|
6.7%
9/135 • 6 years
|
|
Nervous system disorders
Dizziness
|
10.9%
15/138 • 6 years
|
3.7%
5/135 • 6 years
|
|
Gastrointestinal disorders
Dry mouth
|
17.4%
24/138 • 6 years
|
19.3%
26/135 • 6 years
|
|
Nervous system disorders
Dysgeusia
|
9.4%
13/138 • 6 years
|
9.6%
13/135 • 6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
11/138 • 6 years
|
5.2%
7/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.5%
9/138 • 6 years
|
8.1%
11/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.8%
8/138 • 6 years
|
1.5%
2/135 • 6 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.6%
16/138 • 6 years
|
8.9%
12/135 • 6 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.9%
22/138 • 6 years
|
11.1%
15/135 • 6 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.0%
29/138 • 6 years
|
10.4%
14/135 • 6 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
23/138 • 6 years
|
5.9%
8/135 • 6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
26/138 • 6 years
|
10.4%
14/135 • 6 years
|
|
Vascular disorders
Hypotension
|
5.8%
8/138 • 6 years
|
2.2%
3/135 • 6 years
|
|
Psychiatric disorders
Insomnia
|
8.7%
12/138 • 6 years
|
8.1%
11/135 • 6 years
|
|
Investigations
Lymphocyte count decreased
|
4.3%
6/138 • 6 years
|
6.7%
9/135 • 6 years
|
|
Gastrointestinal disorders
Odynophagia
|
5.1%
7/138 • 6 years
|
6.7%
9/135 • 6 years
|
|
Infections and infestations
Oral candidiasis
|
6.5%
9/138 • 6 years
|
4.4%
6/135 • 6 years
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
11/138 • 6 years
|
6.7%
9/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.0%
11/138 • 6 years
|
5.2%
7/135 • 6 years
|
|
Gastrointestinal disorders
Stomatitis
|
9.4%
13/138 • 6 years
|
4.4%
6/135 • 6 years
|
|
Investigations
Weight loss
|
23.2%
32/138 • 6 years
|
20.0%
27/135 • 6 years
|
|
Gastrointestinal disorders
Late RT - Esophagus
|
9.4%
13/138 • 6 years
|
8.1%
11/135 • 6 years
|
|
Gastrointestinal disorders
Late RT - Larynx
|
5.1%
7/138 • 6 years
|
3.7%
5/135 • 6 years
|
|
Gastrointestinal disorders
Late RT - Mucous membrane
|
13.8%
19/138 • 6 years
|
15.6%
21/135 • 6 years
|
|
Gastrointestinal disorders
Late RT - Salivary glands
|
17.4%
24/138 • 6 years
|
18.5%
25/135 • 6 years
|
|
Skin and subcutaneous tissue disorders
Late RT - Skin
|
10.9%
15/138 • 6 years
|
13.3%
18/135 • 6 years
|
|
Metabolism and nutrition disorders
Late RT - Anoxrexia
|
7.2%
10/138 • 6 years
|
10.4%
14/135 • 6 years
|
|
Gastrointestinal disorders
Late - Constipation
|
5.1%
7/138 • 6 years
|
3.7%
5/135 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Late - Cough
|
5.1%
7/138 • 6 years
|
2.2%
3/135 • 6 years
|
|
Gastrointestinal disorders
Late - Dry mouth
|
34.1%
47/138 • 6 years
|
34.1%
46/135 • 6 years
|
|
Gastrointestinal disorders
Late - Dysphagia
|
17.4%
24/138 • 6 years
|
24.4%
33/135 • 6 years
|
|
General disorders
Late - Fatigue
|
13.8%
19/138 • 6 years
|
18.5%
25/135 • 6 years
|
|
Gastrointestinal disorders
Late - Mucosal inflammation
|
8.0%
11/138 • 6 years
|
4.4%
6/135 • 6 years
|
|
Gastrointestinal disorders
Late - Oral pain
|
6.5%
9/138 • 6 years
|
0.74%
1/135 • 6 years
|
|
General disorders
Late - Pain
|
7.2%
10/138 • 6 years
|
10.4%
14/135 • 6 years
|
|
Investigations
Late - Weight loss
|
5.1%
7/138 • 6 years
|
3.7%
5/135 • 6 years
|
|
Nervous system disorders
Late - Dysgeusia
|
6.5%
9/138 • 6 years
|
8.1%
11/135 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.2%
3/138 • 6 years
|
5.9%
8/135 • 6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place