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

Phase 1

Completed

• Conditions: HNSCC,Larynx, Pharynx and Oral Cavity
• Interventions: Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

• Registration Number: NCT01733823
• Lead Sponsor: Danish Head and Neck Cancer Group

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Study Start: 2013-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group C	76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole	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 B	76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole	PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Group D	76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole	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
Group A	76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole	Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Odense; 🇩🇰 Odense, Odense C, Denmark

Aarhus; 🇩🇰 Aarhus, Aarhus C, Denmark

Aalborg; 🇩🇰 Aalborg, Denmark

Herlev; 🇩🇰 Herlev, Denmark