Clinical trial NCT01884259: Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Keywords: local advanced squamous cell carcinoma
Larynx
Hypopharynx
Oropharynx
Cavum oris
docetaxel
cisplatin
5-fluorouracil
Cetuximab
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-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 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

Primary outcomes:
measure: Response Rate (CR, PR)
timeFrame: 3 months after end of therapy
Secondary outcomes:
measure: Overall Response Rate (CR, PR, PD, SD)
timeFrame: until 3 months after therapy
measure: Locoregionally monitoring
timeFrame: after one year
measure: Progression Free Survival (PFS)
timeFrame: 1, 2 and 5 years after start of therapy
measure: Adverse reactions
timeFrame: During treatment and until 60 months after end of radiotherapy
measure: Overall-Survival
timeFrame: 1, 2 and 5 years after start of therapy
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Krems
country: Austria
facility: Landesklinikum Krems
city: Linz
country: Austria
facility: Krankenhaus d. Barmherzigen Schwestern Linz
city: Linz
country: Austria
facility: Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie
city: Salzburg
country: Austria
facility: PMU Salzburg
city: Vienna
country: Austria
facility: Hanusch Krankenhaus Wien
city: Vienna
country: Austria
facility: Universität f. Strahlentherape, AKH Wien
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels GmbH
Study officials:
affiliation: Hanuschkrankenhaus
name: Felix Keil, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: