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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Docetaxel; Drug: Cisplatin; Drug: 5-FU; Radiation: Radiotherapy; Drug: Cetuximab

• Registration Number: NCT00502463
• Lead Sponsor: Austrian South Oncology Group

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.

Study Timeline

• Study First Submitted: 2007-07-15
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Study Start: 2007-10-03
• Primary Completion: 2010-01-19
• Study Completion: 2014-01-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Radiotherapy	3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
Single Arm	Cetuximab	3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
Single Arm	Docetaxel	3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
Single Arm	Cisplatin	3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
Single Arm	5-FU	3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Response rate	24 months	PET-CT or CT, RECIST criteria

Trial Locations

Locations (5)

LKH Feldkirch, Dept. of Radiooncology; 🇦🇹 Feldkirch, Austria

Medical University of Graz, Dept. of Radiooncology; 🇦🇹 Graz, Austria

LKH Leoben Dept. of Hemato-Oncology; 🇦🇹 Leoben, Austria

UK Salzburg, LKH: Universitätsklinik für Innere Medizin III; 🇦🇹 Salzburg, Austria

Medical University of Vienna, Dept. of Medicine I; 🇦🇹 Vienna, Austria