DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Danish Head and Neck Cancer Group
Information provided by (Responsible Party):
Kenneth Jensen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00400426
First received: November 15, 2006
Last updated: June 18, 2013
Last verified: June 2013
  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:


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) [ Time Frame: 11 mths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 11 mths ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 2 mths ] [ Designated as safety issue: Yes ]
  • Other treatments [ Time Frame: 11 mths ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Radiotherapy
    20 Gy in 4 fx
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth Jensen, MD ph.d., University of Aarhus
ClinicalTrials.gov Identifier: NCT00400426     History of Changes
Other Study ID Numbers: DAHANCA 20
Study First Received: November 15, 2006
Last Updated: June 18, 2013
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 July 28, 2014