DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Head and Neck Cancer Group
• Treatments: Antibodies, Monoclonal; Cisplatin; Zalutumumab

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Rhinopharynx or carcinomas of unknown origin

• Distal metastases

• Other malignant diseases (prior or current) except from planocellular skin cancer