Potential Benefits of Radiotherapy in Prone Position for... | NCT01284153

Studies
Potential Benefits of Radiotherapy in Prone Position for Breast Cancer Patients: a Planning Study

NCT01284153

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Jul 1, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Breast Neoplasms
Radiation

Interventions

Not provided

Countries

Belgium

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 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011Actual

Primary Completion Date

Oct 2025Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Jan 25, 2011

First Posted Date

Jan 26, 2011Estimated

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 28, 2024

Last Update Posted Date

Jul 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study has the purpose to investigate the benefit of treating breast cancer patients in prone position. This treatment is compared to the standard technique in our center (supine position with or without respiratory gating). The investigators want to compare the doses on the organs at risk (heart and lungs) in the different techniques.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication for radiotherapy of the breast and /or lymph nodes

Exclusion Criteria:

none ( planning study)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who have an indication for radiotherapy of the breast and/or the lymph nodes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caroline Sweldens, Doctor	Contact	003216347600		caroline.sweldens@uzleuven.be

Overall Officials

Name	Affiliation	Role
Caroline Sweldens, Doctor	UZ Leuven	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven Radiotherapy Department	Recruiting	Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided