NCT01000129

Brief Summary

To demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater accuracy using a new planning method and that this method can be used simply and effectively by those delivering treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 22, 2009

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

October 16, 2009

Last Update Submit

October 21, 2009

Conditions

Bladder Cancer

Keywords

RadiotherapyBladder cancerAdaptive planning

Outcome Measures

Primary Outcomes (1)

  • Assessment performed online at the treatment unit & verified offline by additional observer. Primary endpoint is met if there is greater than 75% concordance between the assessment made online & offline.

Interventions

Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)OTHER

Planning CT scan performed by qualified planning radiographers

Cone beam CT acquisitionOTHER

Cone beam CT acquisition performed by therapy radiographers who have training and experience of using cone beam CT.

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Histologically confirmed invasive carcinoma of the bladder
  • Patient planned to receive hypofractionated radiotherapy to the bladder.
  • No previous pelvic radiotherapy
  • Written informed consent given according to ICH/GCP and national/local regulations.

You may not qualify if:

  • Urinary catheter in situ: the presence of a urinary catheter degrades cone beam image quality and thus images would not be evaluable. Patients with a urinary catheter would not be expected to show variation in bladder filling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Dr Robert Huddart

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Robert Huddart

CONTACT

02086613457robert.huddart@icr.ac.uk

Bernadette Johnson

CONTACT

02086613434bernadette.johnson@rmh.nhs.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 22, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 22, 2009

Record last verified: 2009-10

Locations

GB(1)