DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer | NCT00400426

Studies
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

NCT00400426

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Head and Neck Neoplasms
Recurrence
Neoplasms, Second Primary

Interventions

Radiotherapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Nov 15, 2006

First Submission Date that Met QC Criteria

Nov 15, 2006

First Posted Date

Nov 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Name	Class
Danish Head and Neck Cancer Group	NETWORK

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Procedure	20 Gy in 4 fx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Survival		11 mths
Side effects		2 mths
Other treatments

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Jensen, MD	DAHANCA (Danish Head and Neck Cancer Group)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology		Aarhus		8000 C	Denmark

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D012008	Recurrence
D016609	Neoplasms, Second Primary

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided