Head and Neck Cancer Clinical Trial
Official title:
Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Verified date | July 2014 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Federal Agency for Medicines and Health Products, FAMHP |
Study type | Interventional |
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.
Status | Completed |
Enrollment | 442 |
Est. completion date | January 2011 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN) - Recurrent and/or metastatic SCCHN, not suitable for local therapy Exclusion Criteria: - Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry - Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry - Nasopharyngeal carcinoma |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Research Site | Innsbruck | |
Austria | Research Site | Wien | |
Belgium | Research Site | Bruxelles | |
Belgium | Research Site | Edegem | |
Belgium | Research Site | Gent | |
Czech Republic | Research Site | Ceske Budejovice | |
Czech Republic | Research Site | Prague | |
France | Research Site | Caen | |
France | Research Site | Dijon | |
France | Research Site | Lille | |
France | Research Site | Limoges | |
France | Research Site | Marseille | |
France | Research Site | Montpellier | |
France | Research Site | Nantes-Saint Herblain | |
France | Research Site | Nice | |
France | Research Site | Strasbourg | |
France | Research Site | Toulouse | |
France | Research Site | Tours | |
France | Research Site | Vandoeuvre les Nancy | |
Germany | Research Site | Berlin | |
Germany | Research Site | Essen | |
Germany | Research Site | Frankfurt on the Main | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Munich | |
Germany | Research Site | Oldenburg | |
Germany | Research Site | Stuttgart | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Gyor | |
Hungary | Research Site | Kecskemet | |
Hungary | Research Site | Nyiregyhaza | |
Italy | Research Site | Cuneo | |
Italy | Research Site | Genoa | |
Italy | Research Site | Milan | |
Italy | Research Site | Monserrato | |
Italy | Research Site | Naples | |
Italy | Research Site | Rome | |
Netherlands | Research Site | Amsterdam | |
Netherlands | Research Site | Nijmegen | |
Poland | Research Site | Gdansk | |
Poland | Research Site | Krakow | |
Poland | Research Site | Warszawa | |
Portugal | Research Site | Lisbon | |
Portugal | Research Site | Porto | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | St. Petersburg | |
Slovakia | Research Site | Bratislava | |
Slovakia | Research Site | Kosice | |
Spain | Research Site | Barcelona | |
Spain | Research Site | L'Hospitalet de Llobregat | |
Spain | Research Site | Madrid | |
Spain | Research Site | Malaga | |
Spain | Research Site | San Sebastian | |
Spain | Research Site | Santander | |
Spain | Research Site | Sevilla | |
Spain | Research Site | Valencia | |
Sweden | Research Site | Lind | |
Sweden | Research Site | Örebo | |
Sweden | Research Site | Umea | |
Switzerland | Research Site | Geneva | |
Switzerland | Research Site | Thun | |
Switzerland | Research Site | Zürich | |
Ukraine | Research Site | Donetsk | |
Ukraine | Research Site | Kharkiv | |
Ukraine | Research Site | Kiev | |
Ukraine | Research Site | Sumy | |
United Kingdom | Research Site | Chelmsford | |
United Kingdom | Research Site | Edinburgh | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Manchester | |
United Kingdom | Research Site | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA |
Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
Mesía R, Rivera F, Kawecki A, Rottey S, Hitt R, Kienzer H, Cupissol D, De Raucourt D, Benasso M, Koralewski P, Delord JP, Bokemeyer C, Curran D, Gross A, Vermorken JB. Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first — View Citation
Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in h — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival Time (OS) | Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. | time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 | No |
Secondary | Progression-free Survival Time (PFS) | Duration from randomization until radiological progression according to investigator (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. |
time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 | No |
Secondary | Best Overall Response | The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria). | evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 | No |
Secondary | Disease Control | The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria). | evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 | No |
Secondary | Time to Treatment Failure | Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment. |
Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 | No |
Secondary | Duration of Response | Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria. |
time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 | No |
Secondary | Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status | Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. | at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007 | No |
Secondary | Quality of Life Assessment (EORTC QLQ-C30) Social Functioning | Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning. | at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007 | No |
Secondary | Safety - Number of Patients Experiencing Any Adverse Event | Please refer to Adverse Events section for further details | time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007 | Yes |
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