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OpenTrials
Completed

NCT Number: NCT00963404

Image-Guided Tumorboost of Bladder Cancer

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.

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Key information

Conditions

Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The department of Oncology, Aarhus University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation Boost

Radiation

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

Primary outcomes

  1. Local tumor control

    Time frame: One year

Secondary outcomes

  1. Acute and late adverse effects of the radiotherapy treatment

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2009
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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