NCT00963404

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

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

August 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 3, 2018

Status Verified

January 1, 2018

Enrollment Period

7.4 years

First QC Date

August 20, 2009

Last Update Submit

May 2, 2018

Conditions

Bladder Neoplasms

Keywords

Image-guided RadiotherapyFiducial markerAdverse effects

Outcome Measures

Primary Outcomes (1)

  • Local tumor control

    One year

Secondary Outcomes (1)

  • Acute and late adverse effects of the radiotherapy treatment

    3 years

Study Arms (1)

Tumor-boost

EXPERIMENTAL

Image-guided tumorboost of the bladder cancer.

Radiation: Radiation boost

Interventions

Radiation boostRADIATION

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

Tumor-boost

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The department of Oncology, Aarhus University Hospital

Aarhus, Dk-8000, Denmark

Location

The department of Oncology, Rigshospitalet

Copenhagen, Dk-2100, Denmark

Location

The department of Oncology, Herlev University Hospital

Herlev, Dk-2730, Denmark

Location

The department of Oncology, Odense University Hospital

Odense, Dk-5000, Denmark

Location

Related Links

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

  • Jimmi Sondergaard

    The department of Oncology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 3, 2018

Record last verified: 2018-01

Locations

DK(4)