- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00400426
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
June 18, 2013 updated by: Kenneth Jensen, University of Aarhus
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000 C
- Department of Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
11 mths
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: 11 mths
|
11 mths
|
Side effects
Time Frame: 2 mths
|
2 mths
|
Other treatments
Time Frame: 11 mths
|
11 mths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Jensen, MD, DAHANCA (Danish Head and Neck Cancer Group)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
November 15, 2006
First Submitted That Met QC Criteria
November 15, 2006
First Posted (Estimate)
November 16, 2006
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 18, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAHANCA 20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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