Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate (CR, PR)
Outcome Description:
RECIST criteria
Outcome Time Frame:
3 months after end of therapy
Safety Issue:
No
Principal Investigator
Felix Keil, Prof.Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hanuschkrankenhaus
Authority:
Austria: Agency for Health and Food Safety
Study ID:
AGMT_HNO 2
NCT ID:
NCT01884259
Start Date:
May 2013
Completion Date:
June 2019
Related Keywords:
- 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
- local advanced squamous cell carcinoma
- Larynx
- Hypopharynx
- Oropharynx
- Cavum oris
- docetaxel
- cisplatin
- 5-fluorouracil
- Cetuximab
- Carcinoma
- Carcinoma, Squamous Cell
- Laryngeal Diseases
- Hypopharyngeal Neoplasms
- Laryngeal Neoplasms
- Oropharyngeal Neoplasms