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

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hyperthermia
Radiotherapy
Chemotherapy 5-Fluorouracil
Chemotherapy Cisplatin
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, Hyperthermia, Radiotherapy, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Radiation Therapy, University Hospital ErlangenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Overall survival
Overall survival

Secondary Outcome Measures

Bladder preservation rate
Rate of patients where bladder can be preserved
Disease free survival
Length of survival without disease recurrence

Full Information

First Posted
April 10, 2017
Last Updated
May 25, 2022
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05397262
Brief Title
Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
Acronym
HyBla_RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
December 31, 2098 (Anticipated)
Study Completion Date
December 31, 2099 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, Hyperthermia, Radiotherapy, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Hyperthermia
Other Intervention Name(s)
Thermal therapy or thermotherapy
Intervention Description
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).
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
Intervention Type
Drug
Intervention Name(s)
Chemotherapy 5-Fluorouracil
Intervention Description
600 mg/m^2 civ 120h; d 1-5, 29-33
Intervention Type
Drug
Intervention Name(s)
Chemotherapy Cisplatin
Intervention Description
20 mg/m^2; d1-5, 29-33
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
Participants will be followed for up to 5 years after the end of therapy
Secondary Outcome Measure Information:
Title
Bladder preservation rate
Description
Rate of patients where bladder can be preserved
Time Frame
Participants will be followed for up to 5 years after the end of therapy
Title
Disease free survival
Description
Length of survival without disease recurrence
Time Frame
Participants will be followed for up to 5 years after the end of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Ott, MD
Phone
++49(0)913185
Ext
33968
Email
oliver.ott@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Ott, MD
Organizational Affiliation
Dept. of Radiation Therapy, University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Radiation Therapy, University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Ott, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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