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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Austrian South Oncology Group.
Recruitment status was  Active, not recruiting
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
  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:


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
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, see Learn About Clinical Studies.

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
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014