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NCT00400426 Clinical Trial

DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00400426
Other study ID # DAHANCA 20
Secondary ID
Status Completed
Phase Phase 2
First received November 15, 2006
Last updated June 18, 2013
Start date November 2006
Est. completion date June 2012

Study information
Verified date June 2013
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Radiotherapy
20 Gy in 4 fx

Locations
Country Name City State
Denmark Department of Oncology Aarhus

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and intensity of symptoms before and after radiotherapy (EORTC C30 and H&N35 questionnaires and CTC AE 3.0 toxicity scores) 11 mths No
Secondary Survival 11 mths No
Secondary Side effects 2 mths Yes
Secondary Other treatments 11 mths No
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