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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • 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 Oral Cavity Stage III
  • Squamous Cell Carcinoma of the Oral Cavity Stage IV
  • Squamous Cell Carcinoma of the Oropharynx Stage III
  • Squamous Cell Carcinoma of the Oropharynx Stage IV

NCT number NCT01884259
Study type Interventional
Source Arbeitsgemeinschaft medikamentoese Tumortherapie
Contact
Status Completed
Phase Phase 2
Start date May 2013
Completion date January 13, 2022

See also
  Status Clinical Trial Phase
Terminated NCT02236936 - Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck Phase 3