Clinical trial · Interventional
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
DAHANCA 19: A Randomized Study of the Importance of the EGFr-Inhibitor Zalutumumab for the Outcome After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
NCT00496652CI-TRIAL-00024905completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Zalutumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Radiotherapy (+cisplatin to stage 3+4)
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- 2
- description
- 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)
- interventionNames
- Drug: Zalutumumab
Primary outcomes (1)
- measure
- Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEriksen JG, Maare C, Johansen J, Primdahl H, Bratland A, Kristensen CA, Andersen M, Alsner J, Overgaard J; DAHANCA. DAHANCA19: A randomized phase III study of primary curative (chemo)-radiotherapy and the EGFR-inhibitor zalutumumab for squamous cell carcinoma of the head and neck. Radiother Oncol. 2025 Jul;208:110899. doi: 10.1016/j.radonc.2025.110899. Epub 2025 Apr 19. PMID 40258418