Back to resultsDAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole
Primary Purpose
HNSCC,Larynx, Pharynx and Oral Cavity
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Sponsored by
About this trial
This is an interventional treatment trial for HNSCC,Larynx, Pharynx and Oral Cavity
Eligibility Criteria
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:
- None
Sites / Locations
- Aarhus
- Odense
- Aalborg
- Herlev
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Group D
Arm Description
Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 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
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
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
Outcomes
Primary Outcome Measures
Compliance
Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time
Secondary Outcome Measures
Acute toxicity
In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales
Response rate
Proportion of complete and partial responders
Full Information
NCT ID
NCT01733823
First Posted
November 8, 2012
Last Updated
July 26, 2017
Sponsor
Danish Head and Neck Cancer Group
1. Study Identification
Unique Protocol Identification Number
NCT01733823
Brief Title
DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish Head and Neck Cancer Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HNSCC,Larynx, Pharynx and Oral Cavity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Arm Title
Group B
Arm Type
Experimental
Arm Description
PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Arm Title
Group C
Arm Type
Experimental
Arm Description
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
Arm Title
Group D
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
Primary Outcome Measure Information:
Title
Compliance
Description
Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time
Time Frame
End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)
Secondary Outcome Measure Information:
Title
Acute toxicity
Description
In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales
Time Frame
2 months after end of radiotherapy
Title
Response rate
Description
Proportion of complete and partial responders
Time Frame
2 months after end of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Overgaard, MD, DMSc
Organizational Affiliation
Danish Head and Neck Cancer Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Odense
City
Odense
State/Province
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Aalborg
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole
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