HNSCC,Larynx, Pharynx and Oral CavityPhase 1/2NCT01733823
DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole
A Phase 1/2 study testing 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole in people with HNSCC,Larynx, Pharynx and Oral Cavity, run by Danish Head and Neck Cancer Group at 4 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC,Larynx, Pharynx and Oral Cavity
- What is being tested?
- 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesDenmark
- Study dates
- Jan 2013to Mar 2016
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg
Aalborg, 9100
Aarhus
Aarhus, Aarhus C, 8000
Herlev
Herlev, 2730
Odense
Odense, Odense C, 5000
About this study
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
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
- Being tested
- 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazoleRadiation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole Receives: Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
| Group B | Experimental | PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole Receives: Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
| Group C | Experimental | 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 Receives: Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
| Group D | Experimental | 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 Receives: Radiation: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time
Measured: End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)
Secondary outcomes (2)
Acute toxicity
In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales
Measured: 2 months after end of radiotherapy
Response rate
Proportion of complete and partial responders
Measured: 2 months after end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCC,Larynx, Pharynx and Oral CavityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens Overgaard, MD, DMSc, Principal investigator, Danish Head and Neck Cancer Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733823
- Sponsor's protocol ID
- DAHANCA 28A
- Status last verified
- Jul 2017
- First submitted
- 8 Nov 2012
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No