This trial is active, not recruiting.

Condition head and neck cancer
Treatment radio-immunotherapy
Sponsor Austrian South Oncology Group
Collaborator Medical University of Graz
Start date June 2007
End date February 2009
Trial size 50 participants
Trial identifier NCT00502463, ASOG-HNO1


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

locoregional tumour control
time frame:

Secondary Outcomes

response rate toxicity progression free survival
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Austrian South Oncology Group.