Evaluation of Bladder Volumes in Patients Receiving Radio... | NCT01033682

Studies
Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging

NCT01033682

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Dec 16, 2009Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Rectal Cancer

Interventions

Not provided

Countries

United Kingdom

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

Dec 2009

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

May 2009

Primary Completion Date

Feb 2010Estimated

Completion Date

Feb 2010Estimated

First Submitted Date

Dec 15, 2009

First Submission Date that Met QC Criteria

Dec 15, 2009

First Posted Date

Dec 16, 2009Estimated

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

Dec 15, 2009

Last Update Posted Date

Dec 16, 2009Estimated

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

The purpose of this study is to implement and access a newly developed bladder filling protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment unit.

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

10Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of patients who are able to achieve a bladder volume within +/- 30% of planning volume, on all treatment CBCT (cone beam computed tomography) scans

Secondary Outcomes

Measure	Description	Time Frame
The per-patient standard deviation of bladder volume throughout the course of radiotherapy
The percentage of patients who are unable to follow the bladder filling protocol at any point during their treatment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving radical radiotherapy to rectal malignancies.
Age > 18 years old
No previous lower GI radiotherapy
Written informed consent according to good clinical practice (GCP) and national / local regulations.

Exclusion Criteria:

Patients receiving palliative radiotherapy to rectal malignancies.
Patients receiving radical short course preoperative radiotherapy for rectal malignancies.
Patients unable to give informed consent.

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

Patients receiving radiotherapy to the rectum

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr Diana Tait	Contact	02086613365		diana.tait@rmh.nhs.uk

Overall Officials

Name	Affiliation	Role
Dr Diana Tait	Royal Marsden NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Marsden NHS Foundation Trust	Recruiting	Sutton	Surrey	SM2 5PT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided