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DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University of Aarhus.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Danish Head and Neck Cancer Group
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00400426
First received: November 15, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Recurrence
Neoplasms, Second Primary
 Procedure: Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

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

Estimated Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: November 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400426

Contacts
Contact: Kenneth Jensen, MD +4589492651 kjens@as.aaa.dk

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)
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00400426     History of Changes
Other Study ID Numbers: DAHANCA 20
Study First Received: November 15, 2006
Last Updated: November 15, 2006
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013