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 (HNO-2)

NCT01884259 Phase 2 COMPLETED

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

Details

Lead sponsor	Arbeitsgemeinschaft medikamentoese Tumortherapie
Phase	Phase 2
Status	COMPLETED
Enrolment	100
Start date	2013-05
Completion	2022-01-13

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

Interventions

• Docetaxel
• Cisplatin
• 5-fluorouracil
• Cetuximab Induction
• Cetuximab Radioimmunotherapy
• Boost irradiation

Primary outcomes

• Response Rate (CR, PR) — 3 months after end of therapy
  RECIST criteria

Countries

Austria