Back to resultsDAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
Primary Purpose
Head and Neck Neoplasms, Recurrence, Neoplasms, Second Primary
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Palliative radiotherapy, Recurrent, Head and neck Neoplasm, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Incurable primary or second primary head and neck cancer
- Speaks and reads Danish
- Capable of filling out questionnaires for at leas two months after radiotherapy
- Age>=18 years
- Expected survival> 3months
Sites / Locations
- Department of Oncology
Outcomes
Primary Outcome Measures
Frequency and intensity of symptoms before and after radiotherapy (EORTC C30 and H&N35 questionnaires and CTC AE 3.0 toxicity scores)
Secondary Outcome Measures
Survival
Side effects
Other treatments
Full Information
NCT ID
NCT00400426
First Posted
November 15, 2006
Last Updated
June 18, 2013
Sponsor
University of Aarhus
Collaborators
Danish Head and Neck Cancer Group
1. Study Identification
Unique Protocol Identification Number
NCT00400426
Brief Title
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
Official Title
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Danish Head and Neck Cancer Group
4. Oversight
5. Study Description
Brief Summary
Palliative radiotherapy for head and neck cancer is widely used but the effect and side effects are largely unknown. We will study the effect of short hypofractionated palliative radiotherapy (20 Gy in 4 fractions) on symptom intensity and -frequency as weel as side effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Recurrence, Neoplasms, Second Primary
Keywords
Palliative radiotherapy, Recurrent, Head and neck Neoplasm, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy
Intervention Description
20 Gy in 4 fx
Primary Outcome Measure Information:
Title
Frequency and intensity of symptoms before and after radiotherapy (EORTC C30 and H&N35 questionnaires and CTC AE 3.0 toxicity scores)
Time Frame
11 mths
Secondary Outcome Measure Information:
Title
Survival
Time Frame
11 mths
Title
Side effects
Time Frame
2 mths
Title
Other treatments
Time Frame
11 mths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Incurable primary or second primary head and neck cancer
Speaks and reads Danish
Capable of filling out questionnaires for at leas two months after radiotherapy
Age>=18 years
Expected survival> 3months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
Organizational Affiliation
DAHANCA (Danish Head and Neck Cancer Group)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology
City
Aarhus
ZIP/Postal Code
8000 C
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://www.DAHANCA.dk
Description
Related Info
Learn more about this trial
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
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