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Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE) (DeCIDE)

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ClinicalTrials.gov Identifier: NCT00117572
Recruitment Status : Completed
First Posted : July 7, 2005
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cancer of the Pharynx
Cancer of the Larynx
Cancer of the Nasal Cavity
Paranasal Sinus Neoplasms
Cancer of the Oral Cavity
Interventions: Drug: docetaxel
Drug: cisplatin
Drug: hydroxyurea
Drug: fluorouracil
Procedure: chemotherapy
Procedure: radiotherapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Induction Plus Chemoradiotherapy   Chemoradiotherapy
STARTED   144   141 
COMPLETED   138   135 
NOT COMPLETED   6   6 
Site withdrew before starting treatment                2                3 
Withdrawal by Subject                3                3 
Protocol Violation                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Induction Plus Chemoradiotherapy   Chemoradiotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 138   135   273 
Age 
[Units: Years]
Mean (Full Range)
 56.7 
 (31 to 75) 
 56.9 
 (38 to 82) 
 56.8 
 (31 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  18.1%      17  12.6%      42  15.4% 
Male      113  81.9%      118  87.4%      231  84.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
France   4   3   7 
United States   120   123   243 
Spain   1   0   1 
Croatia   5   4   9 
Russia   8   5   13 


  Outcome Measures

1.  Primary:   Overall Survival: Time From Randomization to Death From Any Cause   [ Time Frame: Up to 6 years ]

2.  Secondary:   Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause   [ Time Frame: Up to 6 years ]

3.  Secondary:   Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause   [ Time Frame: Up to 6 years ]

4.  Secondary:   Failure Pattern (Local/Regional Recurrence)   [ Time Frame: Up to 6 years ]

5.  Secondary:   Failure Pattern (Distant Recurrence)   [ Time Frame: Up to 6 years ]

6.  Secondary:   Quality of Life (FACT H&N)   [ Time Frame: 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. ]

7.  Secondary:   Quality of Life (Normalcy of Diet)   [ Time Frame: 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. ]

8.  Secondary:   Quality of Life (Speech)   [ Time Frame: 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. ]

9.  Secondary:   Quality of Life (McMaster)   [ Time Frame: 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. ]

10.  Secondary:   Quality of Life (FACT H&N)   [ Time Frame: Change from baseline to 1 year (1 year-pre) ]

11.  Secondary:   Quality of Life (Normalcy of Diet)   [ Time Frame: Change from baseline to 1 year (1 year-pre) ]

12.  Secondary:   Quality of Life (Speech)   [ Time Frame: Change from baseline to 1 year (1 year-pre) ]

13.  Secondary:   Quality of Life (McMaster)   [ Time Frame: Change from baseline to 1 year (1 year-pre) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ezra E.W. Cohen
Organization: UC San Diego Moores Cancer Center
e-mail: ecohen@ucsd.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00117572     History of Changes
Other Study ID Numbers: 13362B
First Submitted: June 30, 2005
First Posted: July 7, 2005
Results First Submitted: February 26, 2018
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018