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NCT Number: NCT05397262

Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia

Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer

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Key information

Conditions

Bladder Cancer Body Temperature Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heat Stress Disorders Hyperthermia Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, 91054, Germany

Location status: Recruiting

Location contact

Oliver Ott, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Histologically confirmed bladder cancer
  • M0
  • ECOG-performance status ≤ 2
  • Informed consent

Exclusion criteria

  • Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
  • Cardiac Pacemaker
  • Myocardial infarction within the past 12 months
  • Congestive heart failure
  • Complete bundle branch block
  • New York Heart Association (NYHA) class III or IV heart disease
  • Disease that would preclude TUR, chemoradiation or deep regional hyperthermia
  • Metal implants (lenght > 2cm or dense clusters of marker clips in the pelvis)
  • Active or therapy-resistent bladder infections
  • Pre-existing or concommitant immunodeficiency Syndrom
  • Pregnant or lactating women
  • Patients not willing to use effective contraception during and up to 6 months after therapy

Treatment and study plan

Hyperthermia

Other

Deep Regional Hyperthermia (RHT) 1-2/week up to 10 sessions a type of cancer treatment in which body tissue is exposed to high temperatures (up to 113°F).

Other names: Thermal therapy or thermotherapy

Radiotherapy

Radiation

50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy

Chemotherapy 5-Fluorouracil

Drug

600 mg/m^2 civ 120h; d 1-5, 29-33

Chemotherapy Cisplatin

Drug

20 mg/m^2; d1-5, 29-33

Primary outcomes

  1. Overall survival

    Time frame: Participants will be followed for up to 5 years after the end of therapy

    Overall survival

Secondary outcomes

  1. Bladder preservation rate

    Time frame: Participants will be followed for up to 5 years after the end of therapy

    Rate of patients where bladder can be preserved

  2. Disease free survival

    Time frame: Participants will be followed for up to 5 years after the end of therapy

    Length of survival without disease recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Oliver Ott, MD

CONTACT

[email protected]

++49(0)913185 ext. 33968

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Register-Trial Based on an Agreement of Health Insurances With the Department of Radiation Therapy of the University Hospital Erlangen for the Application of Regional Hyperthermia in Bladder Cancer: Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia

Acronym: HyBla_RCT

Important dates

Study start
2017
Primary completion
2098
Study completion
2099
First posted
May 31, 2022
Registry last updated
May 9, 2024

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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