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Study of Cetuximab With Concomitant-boost Radiotherapy in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00865098
First received: March 18, 2009
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
Results First Received: June 23, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma of the Head and Neck
Intervention: Drug: Cetuximab

  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
Subjects were enrolled in this study at 4 centers in Japan. The first subject was enrolled on 06 March 2009 and the last on 04 January 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
27 subjects were enrolled and 5 were ineligible, not treated, and excluded from the Intention To Treat (ITT)/Safety Population. Reasons: investigator's decision (1 subject), withdrawal of consent (1 subject), inability to perform radiation therapy according to protocol (2 subjects) and inclusion/exclusion criteria not fulfilled (1 subject).

Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Participant Flow:   Overall Study
    Cetuximab With Radiotherapy  
STARTED     22  
COMPLETED     21 [1]
NOT COMPLETED     1  
Progressive disease                 1  
[1] Discontinued from the study due to progressive disease, after completing planned treatment schedule



  Baseline Characteristics
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Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Baseline Measures
    Cetuximab With Radiotherapy  
Number of Participants  
[units: participants]
 		  22  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     15  
Age  
[units: years]
Mean ± Standard Deviation 		  67.6  ± 6.59  
Gender  
[units: participants]
 		 
Female     1  
Male     21  
Region of Enrollment  
[units: participants]
 		 
Japan     22  



  Outcome Measures
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1.  Primary:   Completion Rate   [ Time Frame: time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks ]

Measure Type Primary
Measure Title Completion Rate
Measure Description Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population
Time Frame time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks  
Safety Issue Yes  

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.
ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment

Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Measured Values
    Cetuximab With Radiotherapy  
Number of Participants Analyzed  
[units: participants]
 		  22  
Completion Rate  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		  100  
  ( 84.6 to 100.0 )  

No statistical analysis provided for Completion Rate



2.  Secondary:   Best Response Rate   [ Time Frame: best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required ]

Measure Type Secondary
Measure Title Best Response Rate
Measure Description Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population
Time Frame best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required  
Safety Issue No  

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.
ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment

Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Measured Values
    Cetuximab With Radiotherapy  
Number of Participants Analyzed  
[units: participants]
 		  22  
Best Response Rate  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		  81.8  
  ( 59.7 to 94.8 )  

No statistical analysis provided for Best Response Rate



3.  Secondary:   Safety - Number of Patients Experiencing Any Adverse Event   [ Time Frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks ]

Measure Type Secondary
Measure Title Safety - Number of Patients Experiencing Any Adverse Event
Measure Description Please refer to Adverse Events section for further details
Time Frame time from first dose up to 60 days after last dose of study treatment, ≤18 weeks  
Safety Issue Yes  

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.
ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment

Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Measured Values
    Cetuximab With Radiotherapy  
Number of Participants Analyzed  
[units: participants]
 		  22  
Safety - Number of Patients Experiencing Any Adverse Event  
[units: participants]
 		  22  

No statistical analysis provided for Safety - Number of Patients Experiencing Any Adverse Event



4.  Secondary:   Safety - Number of Patients Experiencing Any Grade 4 Adverse Event   [ Time Frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks ]

Measure Type Secondary
Measure Title Safety - Number of Patients Experiencing Any Grade 4 Adverse Event
Measure Description Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject’s health and well-being, and the ability of the subject to function during the event.
Time Frame time from first dose up to 60 days after last dose of study treatment, ≤18 weeks  
Safety Issue Yes  

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.
ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment

Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Measured Values
    Cetuximab With Radiotherapy  
Number of Participants Analyzed  
[units: participants]
 		  22  
Safety - Number of Patients Experiencing Any Grade 4 Adverse Event  
[units: participants]
 		  2  

No statistical analysis provided for Safety - Number of Patients Experiencing Any Grade 4 Adverse Event



5.  Secondary:   Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction   [ Time Frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks ]

Measure Type Secondary
Measure Title Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction
Measure Description Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
Time Frame time from first dose up to 60 days after last dose of study treatment, ≤18 weeks  
Safety Issue Yes  

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.
ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment

Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Measured Values
    Cetuximab With Radiotherapy  
Number of Participants Analyzed  
[units: participants]
 		  22  
Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction  
[units: participants]
 		  3  

No statistical analysis provided for Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction



6.  Secondary:   Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction   [ Time Frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks ]

Measure Type Secondary
Measure Title Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction
Measure Description Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
Time Frame time from first dose up to 60 days after last dose of study treatment, ≤18 weeks  
Safety Issue Yes  

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.
ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment

Reporting Groups
  Description
Cetuximab With Radiotherapy Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.

Measured Values
    Cetuximab With Radiotherapy  
Number of Participants Analyzed  
[units: participants]
 		  22  
Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction  
[units: participants]
 		  0  

No statistical analysis provided for Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction




  Serious Adverse Events
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  Other Adverse Events
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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.


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: Masataka Ota
Organization: Merck Serono Co., Ltd, Tokyo, Japan
phone: +81 0 3 6853 8611


No publications provided


Responsible Party: Yoshiteru Kimura, Merck Serono Co., Ltd. Tokyo, Japan, an Affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00865098     History of Changes
Other Study ID Numbers: EMR 62241-053
Study First Received: March 18, 2009
Results First Received: June 23, 2011
Last Updated: August 8, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency