HNSCC,Larynx, Pharynx and Oral Cavity
Conditions
Brief summary
P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. The purpose of the study i to investigate the level of co-morbidity and performance status (PS) that allows the combination of all of the above means of treatment intensification
Interventions
RADIATION76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Sponsors
Danish Head and Neck Cancer Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity * P16 negative * T1-4 * N1-3 * M0 * Organ function and performance status allowing radical chemo-radiotherapy
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | End of radiotherapy (approximately 5.5 weeks after start of radiotherapy) | Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 2 months after end of radiotherapy | In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales |
| Response rate | 2 months after end of radiotherapy | Proportion of complete and partial responders |
Countries
Denmark
Outcome results
None listed