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Recruiting NCT05397262

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

No phase Interventional Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperthermia, Radiotherapy, Chemotherapy 5-Fluorouracil, Chemotherapy Cisplatin.
Who it may be relevant to
Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Other Hyperthermia
    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).
  • Radiation Radiotherapy
    50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
  • Drug Chemotherapy 5-Fluorouracil
    600 mg/m\^2 civ 120h; d 1-5, 29-33
  • Drug Chemotherapy Cisplatin
    20 mg/m\^2; d1-5, 29-33

Primary outcome measures

  • Overall survival [Time frame: Participants will be followed for up to 5 years after the end of therapy]
Secondary outcome measures (2)
  • Bladder preservation rate [Time frame: Participants will be followed for up to 5 years after the end of therapy]
  • Disease free survival [Time frame: Participants will be followed for up to 5 years after the end of therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Dept. of Radiation Therapy, University Hospital Erlangen — Erlangen

Identifiers

NCT: NCT05397262 · HyBla_RCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗