Image-Guided Tumorboost of Bladder Cancer | NCT00963404

Studies
Image-Guided Tumorboost of Bladder Cancer

NCT00963404

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

May 3, 2018Actual

Enrollment

19Actual

Phase

Phase 1Phase 2

Conditions

Bladder Neoplasms

Interventions

Radiation boost

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

ID	Type	Description	Link
M-20080210

Status Module

Record Verification Date

Jan 2018

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

Aug 2009

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Aug 20, 2009

First Submission Date that Met QC Criteria

Aug 20, 2009

First Posted Date

Aug 21, 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

May 2, 2018

Last Update Posted Date

May 3, 2018Actual

Name	Class
Aarhus University Hospital	OTHER

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 the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tumor-boost	Experimental	Image-guided tumorboost of the bladder cancer.	Radiation: Radiation boost

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation boost	Radiation	Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.	Tumor-boost

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local tumor control		One year

Secondary Outcomes

Measure	Description	Time Frame
Acute and late adverse effects of the radiotherapy treatment		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Muscle invasive bladder cancer (transitional carcinoma)
Unifocal
TNM stage T2a-4a, N0-1, M0
unfit for radical cystectomy

Exclusion Criteria:

Hyperthyroidism
Multinodular goiter
Pregnancy
Breast feeding
WHO preformance status more than 2
Iodine allergy
MRI or CT contrast media allergy
Bi-lateral hip-prosthesis

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
Jimmi Sondergaard	The department of Oncology, Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The department of Oncology, Aarhus University Hospital		Aarhus		Dk-8000	Denmark
The department of Oncology, Rigshospitalet

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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Browse Branches

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