NCT00887692

Brief Summary

10 patients will be treated alternating daily between prone and supine position for breast radiotherapy to compare set-up accuracy. Prone treatment will be given on the odds days and supine treatment on the even days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

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

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

1.3 years

First QC Date

April 23, 2009

Last Update Submit

October 18, 2010

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Random set-up error

    daily during radiotherapy

Secondary Outcomes (4)

  • Systemic set-up error

    daily during radiotherapy

  • Respiration-related motion amplitude

  • time of treatment delivery

    daily during radiotherapy

  • Dose-volume parameters

    of planning

Interventions

prone and supine positionBEHAVIORAL

patients will be treated alternating daily between prone and supine position for breast radiotherapy.

Eligibility Criteria

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

You may qualify if:

  • female patients
  • multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
  • minimum 18 years
  • informed consent obtained, signed and dated before specific protocol procedures.

You may not qualify if:

  • mastectomy
  • need for axillary irradiation
  • bilateral breast irradiation
  • previous irradiation at the same time
  • pregnant or breastfeeding
  • mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
  • patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Prone PositionSupine Position

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wilfried De Neve, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 19, 2010

Record last verified: 2010-10

Locations

BE(1)