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

HNSCC,Larynx, Pharynx and Oral Cavity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733823
• Other study ID #: DAHANCA 28A
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 8, 2012
• Last updated: July 26, 2017
• Start date: January 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2017
• Source: Danish Head and Neck Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• HNSCC,Larynx, Pharynx and Oral Cavity

Intervention

Radiation:
• 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Locations

Country	Name	City	State
Denmark	Aalborg	Aalborg
Denmark	Aarhus	Aarhus	Aarhus C
Denmark	Herlev	Herlev
Denmark	Odense	Odense	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Acute toxicity	In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales	2 months after end of radiotherapy
Secondary	Response rate	Proportion of complete and partial responders	2 months after end of radiotherapy