NCT00502463

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 3, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2010

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2014

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

July 15, 2007

Last Update Submit

February 5, 2024

Conditions

Head and Neck Cancer

Keywords

head and neck cancer, stage III/IVno prior radiotherapy of head and neck region

Outcome Measures

Primary Outcomes (1)

  • Locoregional tumour control

    Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year.

    12 months

Secondary Outcomes (4)

  • Response rate

    24 months

  • Progression free survival

    24 months

  • Overall survival

    24 months

  • Toxicities

    24 months

Study Arms (1)

Single Arm

EXPERIMENTAL

3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab

Drug: DocetaxelDrug: CisplatinDrug: 5-FURadiation: RadiotherapyDrug: Cetuximab

Interventions

DocetaxelDRUG

75mg/m² day 1

Single Arm
CisplatinDRUG

75mg/m² day 1

Single Arm
5-FUDRUG

750mg/m²/day day 1-5

Single Arm
RadiotherapyRADIATION

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

Single Arm
CetuximabDRUG

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

Single Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed, locally advanced head and neck cancer
  • stage III/IV
  • performance status: ECOG 0-1

You may not qualify if:

  • distant metastases
  • prior radiotherapy of the head and neck region
  • myocardial infarct in the last six months
  • florid peptic ulcer
  • neuropathy grade III/IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

LKH Feldkirch, Dept. of Radiooncology

Feldkirch, 6807, Austria

Location

Medical University of Graz, Dept. of Radiooncology

Graz, 8036, Austria

Location

LKH Leoben Dept. of Hemato-Oncology

Leoben, 8700, Austria

Location

UK Salzburg, LKH: Universitätsklinik für Innere Medizin III

Salzburg, 5020, Austria

Location

Medical University of Vienna, Dept. of Medicine I

Vienna, 1090, Austria

Location

Related 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 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.

    PMID: 22981499RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

DocetaxelCisplatinFluorouracilRadiotherapyCetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Felix Keil, MD

    LKH Leoben, Dept. for Hemato-Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2007

First Posted

July 17, 2007

Study Start

October 3, 2007

Primary Completion

January 19, 2010

Study Completion

January 19, 2014

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

AU(5)