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Completed

NCT Number: NCT00502463

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

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKH Feldkirch, Dept. of Radiooncology, Feldkirch, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

75mg/m² day 1

Cisplatin

Drug

75mg/m² day 1

5-FU

Drug

750mg/m²/day day 1-5

Radiotherapy

Radiation

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

Cetuximab

Drug

250mg/m²/week after an initial loading dose of 400mg/m²

Primary outcomes

  1. 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.

Secondary outcomes

  1. Response rate

    Time frame: 24 months

    PET-CT or CT, RECIST criteria

  2. Progression free survival

    Time frame: 24 months

    PFS is calculated from start of therapy until disease progression or death from any cause.

  3. Overall survival

    Time frame: 24 months

    OS is calculated from start of therapy to death from any cause.

  4. Toxicities

    Time frame: 24 months

    The highest grade of a toxicity per patient is included in the analysis

Sponsors and collaborators

Lead sponsor

Austrian South Oncology Group

Network

Collaborators

  • Change of sponsor 2008: new sponsor AGMT

Registry information

Official study 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

Acronym: ASOG-HNO1

Important dates

Study start
2007
Primary completion
2010
Study completion
2014
First posted
Jul 17, 2007
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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