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

Head and Neck Cancer Clinical Trial

— ASOG-HNO1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502463
• Other study ID #: AGMT_HNO
• Status: Completed
• Phase: N/A
• Start date: October 3, 2007
• Est. completion date: January 19, 2014

Study information

• Verified date: February 2024
• Source: Austrian South Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 19, 2014
• Est. primary completion date: January 19, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Docetaxel
75mg/m² day 1
• Cisplatin
75mg/m² day 1
• 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

Locations

Country	Name	City	State
Austria	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

Sponsors (2)

Lead Sponsor	Collaborator
Austrian South Oncology Group	Change of sponsor 2008: new sponsor AGMT

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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 follow — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional tumour control	Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year.	12 months
Secondary	Response rate	PET-CT or CT, RECIST criteria	24 months
Secondary	Progression free survival	PFS is calculated from start of therapy until disease progression or death from any cause.	24 months
Secondary	Overall survival	OS is calculated from start of therapy to death from any cause.	24 months
Secondary	Toxicities	The highest grade of a toxicity per patient is included in the analysis	24 months