Image-Guided Tumorboost of Bladder Cancer

Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00963404

Enrollment

Registered

2009-08-21

Start date

2009-08-31

Completion date

2017-01-31

Last updated

2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Neoplasms

Keywords

Image-guided Radiotherapy, Fiducial marker, Adverse effects

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.

Interventions

RADIATIONRadiation boost

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Local tumor control	One year

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026