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

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: Head and Neck Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Cisplatin; Drug: 5-FU; Radiation: Radiotherapy; Drug: Cetuximab

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

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

• 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

General Publications

• Keil F, Selzer E, Berghold A, Reinisch S, Kapp KS, De Vries A, Greil R, Bachtiary B, Tinchon C, Anderhuber W, Burian M, Kasparek AK, Elsasser W, Kainz H, Riedl R, Kopp M, Kornek G. Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy with cetuximab for locally advanced squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Jan;49(2):352-9. doi: 10.1016/j.ejca.2012.08.004. Epub 2012 Sep 14.

Study record dates

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: head and neck cancer, stage III/IV; no prior radiotherapy of head and neck region
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Cetuximab
• 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