| July 3, 2007 |
| December 20, 2007 |
| November 2007 |
| |
| Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
| Locoregional control after curative intended radiotherapy/chemoraiotherapy +/- zalutumumab [ Time Frame: 5 years ] |
| Complete list of historical versions of study NCT00496652 on ClinicalTrials.gov Archive Site |
| Disease-specific survival and overall control
Acute and late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] |
| Disease-specific survival and overall control
Acute and late toxicity [ Time Frame: 5 years ] |
| |
| 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 |
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. |
Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. By these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity.
The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further increase the control and survival of patients with Squamous Cell Carcinomas of the Head and Neck when combined with radiotherapy and/or chemotherapy.
The aim of the present study is to determine whether
- The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
- Whether disease-specific survival or overall survival is improved by addition of zalutumumab
- Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
- Acute and late toxicity to the treatment.
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| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Cancer of the Head and Neck |
- Radiation: Radiotherapy
- Drug: Zalutumumab
|
- Active Comparator: Radiotherapy (+cisplatin to stage 3+4)
- 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)
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| |
| |
| Recruiting |
| 600 |
| November 2015 |
|
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
|
| Both |
| 18 Years and older |
| No |
|
|
| Denmark |
| |
| NCT00496652 |
| Jens Overgaard, professor, MD,, DAHANCA |
| DAHANCA 19, Ethical Comittee: 20070091, DKMA: 2612-3486 |
| Danish Head and Neck Cancer Group |
|
| Principal Investigator: |
Jens Overgaard, Prof. MD |
Danish Head and Neck Cancer Group (DAHANCA) |
|
|
| Danish Head and Neck Cancer Group |
| December 2007 |
