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
1 other identifier
interventional
31
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2013
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJuly 28, 2017
July 1, 2017
3.2 years
November 8, 2012
July 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Acute toxicity
2 months after end of radiotherapy
Response rate
2 months after end of radiotherapy
Study Arms (4)
Group A
EXPERIMENTALPerformance 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
EXPERIMENTALPS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Group C
EXPERIMENTALPS 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
EXPERIMENTALPS 2, Charlson: Any Will start inclusion after Group C Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Interventions
Eligibility Criteria
You may qualify if:
- Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity
- P16 negative
- T1-4
- N1-3
- Organ function and performance status allowing radical chemo-radiotherapy
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Aarhus
Aarhus, Aarhus C, 8000, Denmark
Odense
Odense, Odense C, 5000, Denmark
Aalborg
Aalborg, 9100, Denmark
Herlev
Herlev, 2730, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Overgaard, MD, DMSc
Danish Head and Neck Cancer Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2012
First Posted
November 27, 2012
Study Start
January 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
July 28, 2017
Record last verified: 2017-07