Status:
COMPLETED
Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Conditions:
Squamous Cell Carcinoma of the Hypopharynx Stage III
Squamous Cell Carcinoma of the Hypopharynx Stage IV
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-F...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01884259
Start Date
May 1 2013
End Date
January 13 2022
Last Update
May 26 2022
Active Locations (8)
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1
Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6807
2
Landesklinikum Krems
Krems, Austria, A-3500
3
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Austria, A-4010
4
Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie
Linz, Austria, A-4021