Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
NCT ID: NCT05397262
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
1000 participants
INTERVENTIONAL
2017-03-29
2099-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer
NCT00003642
Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery
NCT00777491
Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
NCT00981656
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
NCT00003930
Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
NCT00024349
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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).
Radiotherapy
50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
Chemotherapy 5-Fluorouracil
600 mg/m\^2 civ 120h; d 1-5, 29-33
Chemotherapy Cisplatin
20 mg/m\^2; d1-5, 29-33
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Radiotherapy
50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
Chemotherapy 5-Fluorouracil
600 mg/m\^2 civ 120h; d 1-5, 29-33
Chemotherapy Cisplatin
20 mg/m\^2; d1-5, 29-33
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed bladder cancer
* M0
* ECOG-performance status ≤ 2
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Oliver J. Ott
Principle Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Oliver Ott, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Radiation Therapy, University Hospital Erlangen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept. of Radiation Therapy, University Hospital Erlangen
Erlangen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Oliver Ott, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HyBla_RCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.