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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
|
| Group B | Experimental | PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
|
| Group C | Experimental | PS 0-1 Charlson >=2 Will start inclusion after Group A and B Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
|
| Group D | Experimental | PS 2, Charlson: Any Will start inclusion after Group C Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time | End of radiotherapy (approximately 5.5 weeks after start of radiotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales | 2 months after end of radiotherapy |
| Response rate | Proportion of complete and partial responders |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Overgaard, MD, DMSc | Danish Head and Neck Cancer Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus | Aarhus | Aarhus C | 8000 | Denmark | ||
| Odense |
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| 2 months after end of radiotherapy |
| Odense |
| Odense C |
| 5000 |
| Denmark |
| Aalborg | Aalborg | 9100 | Denmark |
| Herlev | Herlev | 2730 | Denmark |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D009554 | Nimorazole |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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