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

Information source: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: 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

Intervention: Docetaxel (Drug); Cisplatin (Drug); 5-fluorouracil (Drug); Cetuximab Induction (Biological); Cetuximab Radioimmunotherapy (Biological); Boost irradiation (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Arbeitsgemeinschaft medikamentoese Tumortherapie

Official(s) and/or principal investigator(s):
Felix Keil, Prof.Dr., Principal Investigator, Affiliation: Hanuschkrankenhaus


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response Rate (CR, PR)

Secondary outcome:

Overall Response Rate (CR, PR, PD, SD)

Locoregionally monitoring

Progression Free Survival (PFS)



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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Landeskrankenhaus Feldkirch, Feldkirch A-6807, Austria; Recruiting
Alexander DeVries, Prof.Dr., Phone: +43 5522 303, Ext: 3300, Email: alexander.devries@lkhf.at
Alexander DeVries, Prof.Dr., Principal Investigator

Landesklinikum Krems, Krems A-3500, Austria; Recruiting
Gabi Schmoranzer, Phone: +43 6769101268, Email: studienzentrale@krems.lknoe.at
Elisabeth Zwickl-Traxler, MSc, Email: studienzentrale@krems.lknoe.at
Martin Pecherstorfer, Prof.Dr., Principal Investigator

AKH Linz, Innere Medizin 3, Zentrum f. Haematologie u. med. Onkologie, Linz A-4021, Austria; Recruiting
Bettina Pfleger, Phone: +43 7327806, Ext: 6207, Email: bettina.pfleger@akh.linz.at
Elisabeth Morbitzer, Phone: +43 7327806, Ext: 6204, Email: elisabeth.morbitzer@akh.linz.at
Michael A. Fridrik, Univ.Doz.Dr, Principal Investigator

Krankenhaus d. Barmherzigen Schwestern Linz, Linz A-4010, Austria; Recruiting
Magdalena Sturm, DI, Phone: +43 732 7677, Ext: 7521, Email: magdalena.sturm@bhs.at
Martin Burian, Prof.Dr., Principal Investigator

PMU Salzburg, Salzburg 5020, Austria; Recruiting
Michaela Schachner, Mag., Phone: +43 662 4482, Ext: 2847, Email: m.schachner@salk.at
Richard Greil, Prof. Dr., Principal Investigator

Hanusch Krankenhaus Wien, Vienna 1140, Austria; Recruiting
Felix Keil, Prof.Dr., Email: felix.keil@wgkk.at
Mette Hanak, PhD, Email: mette.hanak@wgkk.at
Felix Keil, Prof.Dr., Principal Investigator

Universität f. Strahlentherape, AKH Wien, Vienna A-1090, Austria; Recruiting
Anja Grah, Phone: +43 1 40400, Ext: 2650, Email: anja.grah@meduniwien.ac.at
Gabriela Altorjai, Dr., Principal Investigator

Klinikum Kreuzschwestern Wels GmbH, Wels A-4600, Austria; Recruiting
Ina Pühringer, Phone: +43 7242 415, Ext: 92185, Email: ina.puehringer@klinikum-wegr.at
Bettina Buchbauer, Email: bettina.buchbauer@klinikum-wegr.at
Beate Mayrbäurl, OA Dr., Principal Investigator

Additional Information


Starting date: May 2013
Last updated: July 9, 2015

Page last updated: August 20, 2015

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