Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects (CHANCE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01012258
First received: November 10, 2009
Last updated: January 20, 2014
Last verified: January 2014
Results First Received: July 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma of the Head and Neck
Intervention: Biological: Cetuximab + concomitant boost radiotherapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 70 participants were screened, out of which 4 participants were not treated and 66 participants received the study treatment.

Reporting Groups
  Description
Cetuximab Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.

Participant Flow:   Overall Study
    Cetuximab  
STARTED     66  
COMPLETED     0  
NOT COMPLETED     66  
Death                 14  
Lost to Follow-up                 1  
Adverse Event                 1  
Progressive Disease (PD)                 18  
Symptomatic Deterioration                 1  
Another Anti-cancer Drug Received                 1  
Another Tumor Discovered                 1  
Ongoing                 29  



  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
Cetuximab Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.

Baseline Measures
    Cetuximab  
Number of Participants  
[units: participants]
  66  
Age  
[units: years]
Mean ± Standard Deviation
  55.8  ± 9.5  
Age, Customized  
[units: participants]
 
<65 years     52  
>=65 years     14  
Gender  
[units: participants]
 
Female     7  
Male     59  



  Outcome Measures
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1.  Primary:   Best Overall Response (BOR)   [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant ]


  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: Junliang Cai, Medical Responsible
Organization: Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.
phone: +86 2161131298 ext 173
e-mail: Junliang.Cai@merckgroup.com


No publications provided


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01012258     History of Changes
Other Study ID Numbers: EMR62241-054
Study First Received: November 10, 2009
Results First Received: July 5, 2012
Last Updated: January 20, 2014
Health Authority: China: Food and Drug Administration