Study of Cetuximab With Concomitant-boost Radiotherapy in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
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|ClinicalTrials.gov Identifier: NCT00865098|
Recruitment Status : Completed
First Posted : March 19, 2009
Results First Posted : July 22, 2011
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of the Head and Neck||Drug: Cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Non-randomized, Non-controlled, Multicenter Phase II Study Investigating Cetuximab in Combination With Concomitant-boost Radiotherapy as First-line Treatment for Japanese Patients With Newly Diagnosed Locally Advanced SCCHN.|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
|Experimental: Cetuximab With Radiotherapy||
Patients receive Cetuximab at an initial dose of 400 mg/m^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course. 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receive Cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn.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.
- Completion Rate [ Time Frame: time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks ]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
- 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 ]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
- 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 ]Please refer to Adverse Events section for further details
- 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 ]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.
- 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 ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865098
|Study Director:||Masataka Ota, MD||Merck Serono Co.,Ltd, an Affilate of Merck Serono, Darmstadt, Germany|