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DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00400426
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
Danish Head and Neck Cancer Group
Information provided by (Responsible Party):
Kenneth Jensen, University of Aarhus

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

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Recurrence Neoplasms, Second Primary Procedure: Radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
Study Start Date : November 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Radiotherapy
    20 Gy in 4 fx


Primary Outcome Measures :
  1. 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 Measures :
  1. Survival [ Time Frame: 11 mths ]
  2. Side effects [ Time Frame: 2 mths ]
  3. Other treatments [ Time Frame: 11 mths ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400426


Locations
Denmark
Department of Oncology
Aarhus, Denmark, 8000 C
Sponsors and Collaborators
University of Aarhus
Danish Head and Neck Cancer Group
Investigators
Principal Investigator: Kenneth Jensen, MD DAHANCA (Danish Head and Neck Cancer Group)

Additional Information:
Responsible Party: Kenneth Jensen, MD ph.d., University of Aarhus
ClinicalTrials.gov Identifier: NCT00400426     History of Changes
Other Study ID Numbers: DAHANCA 20
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Kenneth Jensen, University of Aarhus:
Palliative radiotherapy
Recurrent
Head and neck Neoplasm
Quality of life

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Recurrence
Neoplasms, Second Primary
Neoplasms by Site
Disease Attributes
Pathologic Processes