RecruitingNot ApplicableNCT05397262

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

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


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

1,000 participants

Start Date

Mar 29, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding hyperthermia (controlled heat therapy) to radiation or chemo-radiation can help preserve the bladder in people with bladder cancer who want to avoid having the bladder removed surgically. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with bladder cancer confirmed by biopsy - Your cancer has not spread to distant organs - You are well enough to perform daily activities (ECOG status 0–2) - You have provided informed consent **You may NOT be eligible if...** - You have uncontrolled heart disease or a pacemaker - You have had a heart attack recently - You have metal implants in the pelvis area that could interfere with heat treatment - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHyperthermia

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).

RADIATIONRadiotherapy

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

DRUGChemotherapy 5-Fluorouracil

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

DRUGChemotherapy Cisplatin

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


Locations(1)

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, Germany

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NCT05397262


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