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Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study

This study has been terminated.
(Due to slow accrual)
Sponsor:
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01221753
First received: September 21, 2010
Last updated: October 13, 2016
Last verified: October 2016
Results First Received: August 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Squamous Cell Carcinoma of the Head and Neck
Human Papilloma Virus
Interventions: Drug: docetaxel
Drug: cisplatin
Drug: 5-FU
Radiation: IMRT
Drug: cetuximab
Drug: carboplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
7 participants were enrolled between July 2011 and May 2012.

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
TPF Induction Chemotherapy Followed by Chemoradiotherapy Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.

Participant Flow:   Overall Study
    TPF Induction Chemotherapy Followed by Chemoradiotherapy
STARTED   7 
COMPLETED   6 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics
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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
TPF Induction Chemotherapy Followed by Chemoradiotherapy Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.

Baseline Measures
   TPF Induction Chemotherapy Followed by Chemoradiotherapy 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   0 
Male   7 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   6 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   6 
More than one race   0 
Unknown or Not Reported   1 
Region of Enrollment 
[Units: Participants]
 
United States   7 


  Outcome Measures
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1.  Primary:   2-Year Local-Regional Control Rate   [ Time Frame: Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration. ]

2.  Secondary:   4-y Overall Survival Rate   [ Time Frame: Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The study was terminated early due to weak accrual. Because of the designation of study completed at the institution conducting the study, data collected systematically on the case report forms were not accessible for results reporting.


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


Results Point of Contact:  
Name/Title: Robert Haddad, MD
Organization: Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA02215
phone: 617-632-3090
e-mail: robert_haddad@dfci.harvard.edu



Responsible Party: Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01221753     History of Changes
Other Study ID Numbers: 10-038
Study First Received: September 21, 2010
Results First Received: August 15, 2016
Last Updated: October 13, 2016