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This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.
It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Active comparator is 5-fluorouracil for first three cycles. |
|
| B | Experimental | All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Experimental: cetuximab for the first three cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75 mg/m² on day 1 of 21-days cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (CR, PR) | RECIST criteria | 3 months after end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (CR, PR, PD, SD) | RECIST | until 3 months after therapy |
| Locoregionally monitoring | after one year | |
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Inclusion Criteria:
Exclusion Criteria selected:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Keil, Prof.Dr. | Hanuschkrankenhaus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Feldkirch | Feldkirch | A-6807 | Austria | |||
| Landesklinikum Krems |
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| Cisplatin |
| Drug |
75 mg/m² on day 1 of 21-days cycle |
|
| 5-fluorouracil | Drug | 750 mg/m² day 1 to 5 during 24 hours of 21-days cycle |
|
| Cetuximab Induction | Biological | weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days |
|
|
| Cetuximab Radioimmunotherapy | Biological | weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks |
|
|
| Boost irradiation | Radiation | First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks |
|
|
| Progression Free Survival (PFS) |
| 1, 2 and 5 years after start of therapy |
| Adverse reactions | Information about acute toxicity (grade, relation to study drug) during study treatment and until 3 months after end of radiotherapy will be collected for each patient using CTCAE 3.0 criteria list. Information about late toxicity (grade) will be collected after 3 months of radiotherapy and until 60 months after radiotherapy using RTOG/EORTC toxicity criteria. Kind and number of toxicities will be described according to grade. The highest grade of each patient and toxicity will be analysed. | During treatment and until 60 months after end of radiotherapy |
| Overall-Survival | 1, 2 and 5 years after start of therapy |
| Krems |
| A-3500 |
| Austria |
| Krankenhaus d. Barmherzigen Schwestern Linz | Linz | A-4010 | Austria |
| Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie | Linz | A-4021 | Austria |
| PMU Salzburg | Salzburg | 5020 | Austria |
| Hanusch Krankenhaus Wien | Vienna | 1140 | Austria |
| Universität f. Strahlentherape, AKH Wien | Vienna | A-1090 | Austria |
| Klinikum Kreuzschwestern Wels GmbH | Wels | A-4600 | Austria |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| 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 |
| 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 |
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