NCT00400426

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

5.6 years

First QC Date

November 15, 2006

Last Update Submit

June 18, 2013

Conditions

Head and Neck NeoplasmsRecurrenceNeoplasms, Second Primary

Keywords

Palliative radiotherapyRecurrentHead and neck NeoplasmQuality of life

Outcome Measures

Primary Outcomes (1)

  • Frequency and intensity of symptoms before and after radiotherapy (EORTC C30 and H&N35 questionnaires and CTC AE 3.0 toxicity scores)

    11 mths

Secondary Outcomes (3)

  • Survival

    11 mths

  • Side effects

    2 mths

  • Other treatments

    11 mths

Interventions

RadiotherapyPROCEDURE

20 Gy in 4 fx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology

Aarhus, 8000 C, Denmark

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsRecurrenceNeoplasms, Second Primary

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Kenneth Jensen, MD

    DAHANCA (Danish Head and Neck Cancer Group)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD ph.d.

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

DK(1)