Overview

This trial is active, not recruiting.

Conditions squamous cell carcinoma of the hypopharynx stage iii, squamous cell carcinoma of the hypopharynx stage iv, squamous cell carcinoma of the larynx stage iii, squamous cell carcinoma of the larynx stage iv, squamous cell carcinoma of the oropharynx stage iii, squamous cell carcinoma of the oropharynx stage iv, squamous cell carcinoma of the oral cavity stage iii, squamous cell carcinoma of the oral cavity stage iv
Treatments docetaxel, cisplatin, 5-fluorouracil, cetuximab induction, cetuximab radioimmunotherapy, boost irradiation
Phase phase 2
Sponsor Arbeitsgemeinschaft medikamentoese Tumortherapie
Start date May 2013
End date June 2019
Trial size 100 participants
Trial identifier NCT01884259, AGMT_HNO 2

Summary

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
docetaxel
75 mg/m² on day 1 of 21-days cycle
cisplatin
75 mg/m² on day 1 of 21-days cycle
5-fluorouracil
750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
cetuximab radioimmunotherapy Erbitux
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
boost irradiation Concomitant boost-irradiation
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
(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.
docetaxel
75 mg/m² on day 1 of 21-days cycle
cisplatin
75 mg/m² on day 1 of 21-days cycle
cetuximab induction Erbitux
weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
cetuximab radioimmunotherapy Erbitux
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
boost irradiation Concomitant boost-irradiation
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

Primary Outcomes

Measure
Response Rate (CR, PR)
time frame: 3 months after end of therapy

Secondary Outcomes

Measure
Overall Response Rate (CR, PR, PD, SD)
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
Toxicity
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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV - One measureable lesion (CT oder MR) - Age 18 - 75 (including) - Performance Score ECOG 0 - 1 Exclusion Criteria selected: - Distant metastases - ECOG Score >1 - Prior radiation (Head and neck area) - Creatinin Clearance below 60 ml/µl - Acute infections - Neuropathy grade 3 or 4 - Myocardial Infarction within the last 12 months - Acute coronary syndrome or othe clinically significant cardiovascular diseases

Additional Information

Official title Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck
Principal investigator Felix Keil, Prof.Dr.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Arbeitsgemeinschaft medikamentoese Tumortherapie.