Bladder CancerHyBla_RCTNCT05397262
Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
A study testing Hyperthermia, Radiotherapy and Chemotherapy 5-Fluorouracil in people with Bladder Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Hyperthermia, Radiotherapy and Chemotherapy 5-Fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2017to 31 Dec 2099
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed bladder cancer
- M0
- ECOG-performance status ≤ 2
- Informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Radiation Therapy, University Hospital Erlangen
Erlangen, 91054
Oliver Ott, MD
About this study
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
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
- Conditions
- Bladder Cancer
- Being tested
- Hyperthermia, Radiotherapy, Chemotherapy 5-Fluorouracil, Chemotherapy Cisplatin
- Keywords
- bladder cancer, Hyperthermia, Radiotherapy, Chemotherapy
- Medical subject headings
- Urinary Bladder Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaOther
Also called Thermal therapy or thermotherapy
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).
RadiotherapyRadiation
50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
Chemotherapy 5-FluorouracilDrug
600 mg/m^2 civ 120h; d 1-5, 29-33
Chemotherapy CisplatinDrug
20 mg/m^2; d1-5, 29-33
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Hyperthermia; Radiation: Radiotherapy; Drug: Chemotherapy 5-Fluorouracil; Drug: Chemotherapy Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: Participants will be followed for up to 5 years after the end of therapy
Secondary outcomes (2)
Bladder preservation rate
Rate of patients where bladder can be preserved
Measured: Participants will be followed for up to 5 years after the end of therapy
Disease free survival
Length of survival without disease recurrence
Measured: Participants will be followed for up to 5 years after the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start29 Mar 2017
- Primary completion31 Dec 2098 (estimated)
- Study completion31 Dec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver J. Ott, University of Erlangen-Nürnberg Medical School
- Investigators
- Oliver Ott, MD, Principal investigator, Dept. of Radiation Therapy, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397262
- Sponsor's protocol ID
- HyBla_RCT
- Acronym
- HyBla_RCT
- Status last verified
- May 2024
- First submitted
- 10 Apr 2017
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05397262
- Acronym / sponsor ID
- HyBla_RCT / HyBla_RCT
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, Hyperthermia, Radiotherapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 Dec 2098 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | Other | Other: Hyperthermia, Radiation: Radiotherapy, Drug: Chemotherapy 5-Fluorouracil, Drug: Chemotherapy Cisplatin1 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Histologically confirmed bladder cancer
- M0
- ECOG-performance status ≤ 2
- Informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperthermiaAlso: Thermal therapy or thermotherapyDeep 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 | Standard Arm |
| Radiotherapy50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy | Radiation | Standard Arm |
| Chemotherapy 5-Fluorouracil600 mg/m^2 civ 120h; d 1-5, 29-33 | Drug | Standard Arm |
| Chemotherapy Cisplatin20 mg/m^2; d1-5, 29-33 | Drug | Standard Arm |
Primary outcome
Overall survival
Time frame: Participants will be followed for up to 5 years after the end of therapy
Overall survival
2 secondary outcomes
Bladder preservation rate
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver Ott, MD principal investigator
Dept. of Radiation Therapy, University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia, Radiotherapy and Chemotherapy 5-Fluorouracil in people with Bladder Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver Ott, MD (++49(0)913185 ext. 33968, oliver.ott@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Participants will be followed for up to 5 years after the end of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.