NCT05397262

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
897mo left

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2017Dec 2099

Study Start

First participant enrolled

March 29, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
5.1 years until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
76.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2098

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2099

Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

81.8 years

First QC Date

April 10, 2017

Last Update Submit

May 8, 2024

Conditions

Bladder Cancer

Keywords

bladder cancerHyperthermiaRadiotherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival

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

Secondary Outcomes (2)

  • Bladder preservation rate

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

  • Disease free survival

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

Study Arms (1)

Standard Arm

OTHER

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: HyperthermiaRadiation: RadiotherapyDrug: Chemotherapy 5-FluorouracilDrug: Chemotherapy Cisplatin

Interventions

HyperthermiaOTHER

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).

Also known as: Thermal therapy or thermotherapy
Standard Arm
RadiotherapyRADIATION

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

Standard Arm
Chemotherapy 5-FluorouracilDRUG

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

Standard Arm
Chemotherapy CisplatinDRUG

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

Standard Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Urinary Bladder NeoplasmsHyperthermia

Interventions

DiathermyHyperthermia, InducedRadiotherapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Oliver Ott, MD

    Dept. of Radiation Therapy, University Hospital Erlangen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Ott, MD

CONTACT

++49(0)913185oliver.ott@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 10, 2017

First Posted

May 31, 2022

Study Start

March 29, 2017

Primary Completion (Estimated)

December 31, 2098

Study Completion (Estimated)

December 31, 2099

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

DE(1)