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

February 5, 2024 updated by: Austrian South Oncology Group

Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • LKH Feldkirch, Dept. of Radiooncology
      • Graz, Austria, 8036
        • Medical University of Graz, Dept. of Radiooncology
      • Leoben, Austria, 8700
        • LKH Leoben Dept. of Hemato-Oncology
      • Salzburg, Austria, 5020
        • UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
      • Vienna, Austria, 1090
        • Medical University of Vienna, Dept. of Medicine I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
Drug: Docetaxel
75mg/m² day 1
Drug: Cisplatin
75mg/m² day 1
Drug: 5-FU
750mg/m²/day day 1-5
Radiation: Radiotherapy
standard fraction up to a total dose of 70Gy/35 fractions/7weeks or accelerated regimen, up to a total dose of 72Gy/42 fractions over 6 weeks
Drug: Cetuximab
250mg/m²/week after an initial loading dose of 400mg/m²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional tumour control
Time Frame: 12 months
Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 24 months
PET-CT or CT, RECIST criteria
24 months
Progression free survival
Time Frame: 24 months
PFS is calculated from start of therapy until disease progression or death from any cause.
24 months
Overall survival
Time Frame: 24 months
OS is calculated from start of therapy to death from any cause.
24 months
Toxicities
Time Frame: 24 months
The highest grade of a toxicity per patient is included in the analysis
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian South Oncology Group

Collaborators

Change of sponsor 2008: new sponsor AGMT

Investigators

  • Study Chair: Felix Keil, MD, LKH Leoben, Dept. for Hemato-Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2007

Primary Completion (Actual)

January 19, 2010

Study Completion (Actual)

January 19, 2014

Study Registration Dates

First Submitted

July 15, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimated)

July 17, 2007

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT_HNO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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