NCT01733823

DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole

Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole for Patients With Stage III-IV p16 Negative Squamous Cell Cancer (SCC) of the Larynx, Pharynx and Oral Cavity

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Danish Head and Neck Cancer Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• HNSCC,Larynx, Pharynx and Oral Cavity

Interventions

Type	Name	Description
RADIATION	76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2012-11-27
• Last updated: 2017-07-28

Locations

4 sites across 1 country: Denmark