Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00547157
First received: October 18, 2007
Last updated: July 10, 2014
Last verified: July 2014
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Head and Neck Cancer
Oncology
Squamous Cell Carcinoma
Interventions: Drug: Panitumumab
Drug: Cisplatin

  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
152 subjects were enrolled with 90 subjects randomized to panitumumab plus radiotherapy arm, and 62 subjects randomized to chemoradiotherapy arm.

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
Panitumumab Plus Radiotherapy Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
Chemoradiotherapy Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy

Participant Flow:   Overall Study
    Panitumumab Plus Radiotherapy     Chemoradiotherapy  
STARTED     90     62  
COMPLETED     41     39  
NOT COMPLETED     49     23  
Unknown                 1                 0  
Death                 38                 18  
Withdrawal by Subject                 3                 1  
Administrative decision                 3                 2  
Lost to Follow-up                 4                 2  



  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
Panitumumab Plus Radiotherpy Consists of Panitumumab and Radiotherpy
Chemoradiotherapy Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
Total Total of all reporting groups

Baseline Measures
    Panitumumab Plus Radiotherpy     Chemoradiotherapy     Total  
Number of Participants  
[units: participants]
  90     62     152  
Age  
[units: Years]
Mean ± Standard Deviation
  56.9  ± 8.3     57.4  ± 7.9     57.1  ± 8.1  
Gender  
[units: Participants]
     
Female     18     7     25  
Male     72     55     127  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     0     00     0  
Black or African American     0     0     0  
White     88     60     148  
Hispanic or Latino     2     2     4  
Radiotherapy Delivery Modality  
[units: Participants]
     
IMRT     49     32     81  
3D-CRT     41     29     70  
Missing     0     1     1  
Primary Tumor Site  
[units: Participants]
     
Oropharynx/Larynx     66     44     110  
Oral Cavity/Hypopharynx     24     18     42  
Nodal Status [1]
[units: Participants]
     
N0     11     7     18  
N+     79     55     134  
Tumor Stage [2]
[units: Participants]
     
T1-3     58     39     97  
T4     32     23     55  
[1] N0: No regional lymph node involvement; N+: Regional lymph node involvement
[2] Tumor stage is determined according to TNM staging system. The tumor, node, and metastasis (TNM) staging system integrates clinical information, including that derived from endoscopy and radiological evaluation. Together the TNM classifications determine the overall clinical stage (I, II, III or IV).



  Outcome Measures
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1.  Primary:   Local Regional Control Rate at 2 Years   [ Time Frame: from study day 1 to 2 years ]

2.  Secondary:   Duration of Local Regional Control   [ Time Frame: maximum follow up time 46.2 months ]

3.  Secondary:   Progression-free Survival   [ Time Frame: maximum follow up time 46.2 months ]

4.  Secondary:   Overall Survival   [ Time Frame: maximum follow up time 46.2 months ]

5.  Secondary:   ORR by 6 Months - Central   [ Time Frame: From randomization to 6 months ]

6.  Secondary:   CRR by 6 Months - Central   [ Time Frame: From randomization till 6 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00547157     History of Changes
Other Study ID Numbers: 20062079, CONCERT2
Study First Received: October 18, 2007
Results First Received: December 16, 2013
Last Updated: July 10, 2014
Health Authority: Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Mexico: COFEPRIS
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration