Image-Guided Tumorboost of Bladder Cancer

NCT ID: NCT00963404

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Conditions

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Bladder Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tumor-boost

Image-guided tumorboost of the bladder cancer.

Group Type EXPERIMENTAL

Radiation boost

Intervention Type RADIATION

Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.

Interventions

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Radiation boost

Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jimmi Sondergaard

Role: PRINCIPAL_INVESTIGATOR

The department of Oncology, Aarhus University Hospital

Locations

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The department of Oncology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

The department of Oncology, Rigshospitalet

Copenhagen, , Denmark

Site Status

The department of Oncology, Herlev University Hospital

Herlev, , Denmark

Site Status

The department of Oncology, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Related Links

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Other Identifiers

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M-20080210

Identifier Type: -

Identifier Source: secondary_id

CIRRO IP 070109 DaBlaCa-1

Identifier Type: -

Identifier Source: org_study_id

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