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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502463

Acronym

ASOG-HNO1

Enrollment

Registered

2007-07-17

Start date

2007-10-03

Completion date

2014-01-19

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

head and neck cancer, stage III/IV, no prior radiotherapy of head and neck region

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.

Interventions

DRUGDocetaxel

75mg/m² day 1

DRUGCisplatin

75mg/m² day 1

DRUG5-FU

750mg/m²/day day 1-5

RADIATIONRadiotherapy

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

DRUGCetuximab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026