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
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 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) Toxicity Overall-Survival
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Sponsor
Starting date: May 2013
Last updated: July 9, 2015
|