Spots Global Cancer Trial Database for Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN

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Trial Identification

Brief Title: Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN

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

Study ID: NCT01884259

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

Cetuximab Radioimmunotherapy

Boost irradiation

Study Description

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

Detailed 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.