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| Name | Class |
|---|---|
| Change of sponsor 2008: new sponsor AGMT | UNKNOWN |
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The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;
Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | 3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75mg/m² day 1 |
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional tumour control | Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | PET-CT or CT, RECIST criteria | 24 months |
| Progression free survival | PFS is calculated from start of therapy until disease progression or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Keil, MD | LKH Leoben, Dept. for Hemato-Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Feldkirch, Dept. of Radiooncology | Feldkirch | 6807 | Austria | |||
| Medical University of Graz, Dept. of Radiooncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22981499 | Result | Keil F, Selzer E, Berghold A, Reinisch S, Kapp KS, De Vries A, Greil R, Bachtiary B, Tinchon C, Anderhuber W, Burian M, Kasparek AK, Elsasser W, Kainz H, Riedl R, Kopp M, Kornek G. Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy with cetuximab for locally advanced squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Jan;49(2):352-9. doi: 10.1016/j.ejca.2012.08.004. Epub 2012 Sep 14. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
75mg/m² day 1 |
|
| 5-FU | Drug | 750mg/m²/day day 1-5 |
|
| Radiotherapy | Radiation | standard fraction up to a total dose of 70Gy/35 fractions/7weeks or accelerated regimen, up to a total dose of 72Gy/42 fractions over 6 weeks |
|
| Cetuximab | Drug | 250mg/m²/week after an initial loading dose of 400mg/m² |
|
| 24 months |
| Overall survival | OS is calculated from start of therapy to death from any cause. | 24 months |
| Toxicities | The highest grade of a toxicity per patient is included in the analysis | 24 months |
| Graz |
| 8036 |
| Austria |
| LKH Leoben Dept. of Hemato-Oncology | Leoben | 8700 | Austria |
| UK Salzburg, LKH: Universitätsklinik für Innere Medizin III | Salzburg | 5020 | Austria |
| Medical University of Vienna, Dept. of Medicine I | Vienna | 1090 | Austria |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |