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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
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

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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/┬Ál

- 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

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