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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
radio-immunotherapy
Sponsored by
Austrian South Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, stage III/IV, no prior radiotherapy of head and neck region

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH Feldkirch, Dept. of Radiooncology
  • Medical University of Graz, Dept. of Radiooncology
  • LKH Leoben Dept. of Hemato-Oncology
  • Medical University of Vienna, Dept. of Medicine I

Outcomes

Primary Outcome Measures

locoregional tumour control

Secondary Outcome Measures

response rate toxicity progression free survival

Full Information

First Posted
July 15, 2007
Last Updated
July 30, 2009
Sponsor
Austrian South Oncology Group
Collaborators
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00502463
Brief Title
Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial
Acronym
ASOG-HNO1
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Austrian South Oncology Group
Collaborators
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, stage III/IV, no prior radiotherapy of head and neck region

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
radio-immunotherapy
Primary Outcome Measure Information:
Title
locoregional tumour control
Secondary Outcome Measure Information:
Title
response rate toxicity progression free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Keil, MD
Organizational Affiliation
LKH Leoben, Dept. for Hemato-Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
LKH Feldkirch, Dept. of Radiooncology
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Medical University of Graz, Dept. of Radiooncology
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
LKH Leoben Dept. of Hemato-Oncology
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Facility Name
Medical University of Vienna, Dept. of Medicine I
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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