A Phase 2 interventional study of Docetaxel and Cisplatin in Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV and Squamous Cell Carcinoma of the Larynx Stage III, sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie. Completed at 8 sites in Austria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 100 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Arbeitsgemeinschaft medikamentoese Tumortherapie is the lead sponsor of 43 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria selected:
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.
Drug: Docetaxel · Drug: Cisplatin · Drug: 5-fluorouracil · Biological: Cetuximab Radioimmunotherapy · Radiation: Boost irradiation
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.
Drug: Docetaxel · Drug: Cisplatin · Biological: Cetuximab Induction · Biological: Cetuximab Radioimmunotherapy · Radiation: Boost irradiation
75 mg/m² on day 1 of 21-days cycle
75 mg/m² on day 1 of 21-days cycle
750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
Also known as: Erbitux
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
Also known as: Erbitux
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
Also known as: Concomitant boost-irradiation
Response Rate (CR, PR)
RECIST criteria
Time frame: 3 months after end of therapy
Overall Response Rate (CR, PR, PD, SD)
RECIST
Time frame: until 3 months after therapy
Locoregionally monitoring
Time frame: after one year
Progression Free Survival (PFS)
Time frame: 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.
Time frame: During treatment and until 60 months after end of radiotherapy
Overall-Survival
Time frame: 1, 2 and 5 years after start of therapy
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Arbeitsgemeinschaft medikamentoese Tumortherapie