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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00502463
Recruitment Status : Unknown
Verified July 2009 by Austrian South Oncology Group.
Recruitment status was:  Active, not recruiting
First Posted : July 17, 2007
Last Update Posted : July 31, 2009
Medical University of Graz
Information provided by:
Austrian South Oncology Group

Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: radio-immunotherapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Actual Primary Completion Date : February 2009
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. locoregional tumour control

Secondary Outcome Measures :
  1. response rate toxicity progression free survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00502463

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
Study Chair: Felix Keil, MD LKH Leoben, Dept. for Hemato-Oncology Identifier: NCT00502463     History of Changes
Other Study ID Numbers: ASOG-HNO1
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: July 31, 2009
Last Verified: July 2009

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