Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00095875
First received: November 9, 2004
Last updated: October 25, 2013
Last verified: October 2013
Results First Received: May 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: carboplatin
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil

  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
Between August 24, 2004 and December 29, 2008 145 patients were enrolled across 16 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomly assigned in a 1:1 ratio to recieve either induction chemotherapy with 3 cycles of TPF followed by concurrent chemoradiotherapy with either docetaxel or carboplatin or concurrent chemoradiotherapy alone with 2 cycles of bolus cisplatin.

Reporting Groups
  Description
Arm I

Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks

carboplatin : Given IV

fluorouracil : Given IV

docetaxel : Given IV

Arm II

Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks


Participant Flow:   Overall Study
    Arm I     Arm II  
STARTED     70     75  
COMPLETED     56     66  
NOT COMPLETED     14     9  



  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
Arm I

Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks

carboplatin : Given IV

fluorouracil : Given IV

docetaxel : Given IV

Arm II

Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Total  
Number of Participants  
[units: participants]
  70     75     145  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     59     66     125  
>=65 years     11     9     20  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 9     54  ± 8     55  ± 8.4  
Gender  
[units: participants]
     
Female     6     12     18  
Male     64     63     127  
Region of Enrollment  
[units: participants]
     
United States     69     69     138  
Germany     1     6     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: 3-years ]

2.  Secondary:   Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description Only the following adverse events were records: mucositis, febrile neutropenia, pain, xerostomia, feeding tube placement, and neuropathy which was deemed pertinent to the comparision of regimens in this setting.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Arm I

Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks

carboplatin : Given IV

fluorouracil : Given IV

docetaxel : Given IV

Arm II

Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks


Other Adverse Events
    Arm I     Arm II  
Total, other (not including serious) adverse events      
# participants affected / at risk     70/70     75/75  
Gastrointestinal disorders      
Mucositis      
# participants affected / at risk     29/70 (41.43%)     44/75 (58.67%)  
Xerostomia      
# participants affected / at risk     42/70 (60.00%)     46/75 (61.33%)  
General disorders      
Pain      
# participants affected / at risk     41/70 (58.57%)     35/75 (46.67%)  
Immune system disorders      
Neuropathy      
# participants affected / at risk     22/70 (31.43%)     18/75 (24.00%)  



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


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.  


Results Point of Contact:  
Name/Title: Robert I Haddad, MD
Organization: Dana Farber Cancer Institute
phone: 617-632-3090
e-mail: rihaddad@partners.org


Publications of Results:

Responsible Party: Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00095875     History of Changes
Obsolete Identifiers: NCT00705068
Other Study ID Numbers: DFCI 04-006, P30CA006516, CDR0000393548
Study First Received: November 9, 2004
Results First Received: May 15, 2013
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board