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Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning
Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.
Inclusion:
Patients must fulfill the following:
Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with HART-CN | Experimental | HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HART-CN | Radiation | HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loco-regional failure | loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed). | Year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Death from all causes | Year 3 |
| Acute radiation related morbidity | Month 3 | |
| Late radiation related morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Overgaard, MD, DMSc | Contact | +45 78462629 | jens@oncology.au.dk | |
| Mette Saksoe, MD | Contact | +45 78462629 | mette.saksoe@oncology.au.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Experimental Clinical Oncology, Aarhus University Hospital | Recruiting | Aarhus | 8000 C | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23083497 | Result | Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Year 3 |
| Disease-specific death | Disease-specific death is defined as death from or with the cancer in question; | Year 3 |