NCT00496652

Brief Summary

The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
619

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

4.7 years

First QC Date

July 3, 2007

Last Update Submit

November 22, 2016

Conditions

Cancer of the Head and Neck

Keywords

Squamous Cell Carcinomas of the Head and NeckEpidermal Growth Factor receptorAntibodyRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab

    5 years

Secondary Outcomes (1)

  • Disease-specific survival and overall control Acute and late toxicity

    5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Radiotherapy (+cisplatin to stage 3+4)

Radiation: Radiotherapy

2

EXPERIMENTAL

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4) + Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Drug: Zalutumumab

Interventions

RadiotherapyRADIATION

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)

1
ZalutumumabDRUG

Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

2

Eligibility Criteria

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

You may qualify if:

  • Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx)
  • Curative intent and no prior treatment
  • Age \> 18 years
  • WHO performance 0-2 (incl.)
  • No prior treatment with EGFr-I
  • Informed consent according to local guidelines and national law
  • The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
  • Fertile women must use contraceptive devices (IUD or oral contraceptives)

You may not qualify if:

  • Rhinopharynx or carcinomas of unknown origin
  • Distal metastases
  • Other malignant diseases (prior or current) except from planocellular skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, 8000 N, Denmark

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapyzalutumumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jens Overgaard, Prof. MD

    Danish Head and Neck Cancer Group (DAHANCA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 4, 2007

Study Start

November 1, 2007

Primary Completion

July 1, 2012

Study Completion

November 1, 2016

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

DK(1)