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

May 25, 2022 updated by: Oliver J. Ott, University of Erlangen-Nürnberg Medical School

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Dept. of Radiation Therapy, University Hospital Erlangen
        • Contact:
          • Oliver Ott, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Standard Arm

1 Arm: combination Treatment: Deep regional hyperthermia: 1-2/week up to 10 sessions Radiotherapy: 50.4Gy + Boost 5.4Gy (R0) or 9.0Gy (R1/2)

Chemotherapy:

5-Fluorouracil 600mg/m^2, civ 120h; d1-5, 29-3

Chemotherapy:

Cisplatin 20mg/m^2; d1-5, 29-33
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).
Other Names:
  • Thermal therapy or thermotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Participants will be followed for up to 5 years after the end of therapy
Overall survival
Participants will be followed for up to 5 years after the end of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Length of survival without disease recurrence
Participants will be followed for up to 5 years after the end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Oliver Ott, MD, Dept. of Radiation Therapy, University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2017

Primary Completion (ANTICIPATED)

December 31, 2098

Study Completion (ANTICIPATED)

December 31, 2099

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

May 25, 2022

First Posted (ACTUAL)

May 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HyBla_RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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