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Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial (ASOG-HNO1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medical University of Graz
Information provided by:
Austrian South Oncology Group
ClinicalTrials.gov Identifier:
NCT00502463
First received: July 15, 2007
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV


Condition Intervention
Head and Neck Cancer
 Procedure: radio-immunotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Austrian South Oncology Group:

Primary Outcome Measures:
  • locoregional tumour control

Secondary Outcome Measures:
  • response rate toxicity progression free survival

Enrollment: 50
Study Start Date: June 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:

3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;

Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed, locally advanced head and neck cancer
  • stage III/IV
  • performance status: ECOG 0-1

Exclusion Criteria:

  • distant metastases
  • prior radiotherapy of the head and neck region
  • myocardial infarct in the last six months
  • florid peptic ulcer
  • neuropathy grade III/IV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502463

Locations
Austria
LKH Feldkirch, Dept. of Radiooncology
Feldkirch, Austria, 6807
Medical University of Graz, Dept. of Radiooncology
Graz, Austria, 8036
LKH Leoben Dept. of Hemato-Oncology
Leoben, Austria, 8700
Medical University of Vienna, Dept. of Medicine I
Vienna, Austria, 1090
Sponsors and Collaborators
Austrian South Oncology Group
Medical University of Graz
Investigators
Study Chair: Felix Keil, MD LKH Leoben, Dept. for Hemato-Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00502463     History of Changes
Other Study ID Numbers: ASOG-HNO1
Study First Received: July 15, 2007
Last Updated: July 30, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Austrian South Oncology Group:
head and neck cancer, stage III/IV
no prior radiotherapy of head and neck region

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013