Bladder Cancer (BC)LORUPNCT07524426
Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment
A study of Bladder Cancer (BC), run by Umeå University at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to improve the quality of life and prolong survival in bladder cancer patients unfit for curative treatment. The trial will compare the survival and symptoms of patients randomized to either local radiotherapy in addition to standard of care or standard of care alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer (BC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteSweden
- Study dates
- 3 Jun 2026to Jun 2034
- 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
- Oral and written consent
- Histologically confirmed MIBC with urothelial component
- Male or female participants ≥ 18 years old
- Deemed not to benefit from curative treatment at a multidisciplinary tumour conference (MDT) or having declined curative treatment of their own accord.
Who cannot join
- Clinical Fragility Scale score ≥8
- Previous pelvic RT with significant overlap
- Visceral or bone metastases on CT scan
- Multiple (>3) lymph node metastases with a measurement of >2 cm on CT scan
- Planed for systemic treatment at the time of inclusion.
- Local RT to the bladder indicated for the palliation of symptoms at the time of inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Norrlands University Hosital
Umeå, Västerbotten County, 90185
Karin Söderkvist, MD, PhD, +46(0)90-785 00 00, karin.soderkvist@umu.se
About this study
Official title: Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment; a Prospective Randomized Phase III Trial.
The goal of this clinical trial is to improve the quality of life and prolong survival in bladder cancer patients unfit for curative treatment. The trial will compare the survival and symptoms of patients randomized to either local radiotherapy in addition to standard of care or standard of care alone.
Using modern radiotherapy techniques, including hypofractionation and image-guided treatment adaptation, the aim is to deliver a well-tolerated, time-efficient, and effective treatment strategy for these patients.
The trial collaborates with two ongoing exploratory biomarker studies collecting and analyzing potential biomarkers in urothelial bladder cancer. The hope is to provide biomarkers for prognosis and treatment response which is essential to ensure bladder cancer patients individualized treatment in the future, like those with breast and prostate cancer.
Read the detailed description
Around 700 individuals in Sweden are diagnosed each year with muscle-invasive bladder cancer (MIBC), and a similar number die annually from the disease (SVF RCC 2023). With a median age at diagnosis approaching 76 years (Swedish National Quality Registry for Urothelial Carcinoma), the incidence is expected to rise as the population ages.
Due to advanced age and comorbidity, many patients are not eligible for the demanding multimodal treatments used with curative intent. Recently introduced systemic therapies for palliation, such as antibody-drug conjugates and immunotherapy, also require a WHO performance status <2 and regular hospital-based administration. Consequently, up to 30% of patients receive no tumor-directed therapy at diagnosis (Swedish National Quality Registry for Urothelial Carcinoma).
Without treatment, MIBC often progresses rapidly, with a median overall survival of approximately 12 months in this cohort. Symptom burden is substantial, commonly involving pain, bleeding, and urinary tract obstruction, which frequently require repeated hospital admissions late in the disease trajectory.
Radiation therapy (RT) is an established curative modality in bladder cancer and is well documented for symptom palliation. In other malignancies, such as prostate cancer, limited radiation doses have been shown to prolong survival and reduce the development of distressing symptoms. Although some studies indicate similar benefits in bladder cancer, a clear survival effect has not been demonstrated, representing an important knowledge gap in the management of a common cancer type.
The LORUP project builds on existing translational research infrastructures to address this gap. Its aim is to develop a treatment strategy for MIBC patients unfit for curative therapy, focused on improving quality of life by reducing symptom burden and potentially prolonging survival, while maintaining a low treatment burden and minimal side effects.
- Conditions
- Bladder Cancer (BC)
- Being tested
- Local hypo fractionated adaptive radiotherapy and Standard of Care, Standard of Care (Investigator Choice)
- Keywords
- LORUP, Bladder cancer, local radiotherapy, adaptive radiotherapy, Patient Reported Outcomes, Overall survival
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local hypo fractionated adaptive radiotherapy and Standard of CareRadiation
Patients randomized to the radiotherapy (RT) arm will receive external beam radiotherapy to the whole urinary bladder as well as Standard of Care.
Intensity-modulated Radiotherapy will be delivered using an adaptive treatment strategy, permitting either:
- Plan-of-the-day (PoD) adaptive radiotherapy using a predefined library of plans, or
- Online adaptive radiotherapy (oART) with daily re-contouring and re-optimisation to the anatomy of the day.
The choice of adaptive strategy (PoD vs oART) and imaging modality (CBCT- or MR-based) is at institutional discretion, provided all protocol-specified target coverage objectives and organ-at-risk (OAR) constraints are met.
The prescribed dose is 21 Gy in 3 fractions of 7 Gy, delivered every other day.
Standard of Care (Investigator Choice)Other
All applicable palliative treatments associated with the Standard of Care, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed
| Study group | Role | What they receive |
|---|---|---|
| Arm A - RT and SoC | Experimental | Local hypo fractionated adaptive radiotherapy to the bladder, 7 Gy in 3 fractions delivered every other day (eod) prescribed in addition to standard of care. Receives: Radiation: Local hypo fractionated adaptive radiotherapy and Standard of Care |
| Arm B - SoC | Active comparator | Standard of care. All applicable palliative treatments, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed. Receives: Other: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From date of randomization until the date of death from any cause assessed up to a minimum of 36 months
Secondary outcomes (8)
Disease specific Survival
Measured: From date of randomization until the date of death by MIBC assessed up to a minimum of 36 months
Progression-free survival
Any symptoms associated with tumor progression, including but not restricted to the AESI of the study.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to a minimum of 36 months
Radiological progression-free survival
Defined as; 1. new lesion as compared to baseline and/or 2) increase of longest tumour diameter by 20% as assessed by local investigator.
Measured: Time from randomization to the date of the first documented radiological progression or death, whichever comes first, assessed up to a minimum of 36 months
Start of systemic anti-tumour treatment
Start of any systemic anti-tumour treatment, such as immunotherapy, tyrosine kinase inhibitors, chemotherapy or antibody-conjugates
Measured: Time from randomization to start of systemic anti-tumour treatment assessed up to a minimum of 36 months
Health related quality of life, HRQoL
Global HRQoL will be evaluated with the EORTC QLQ C15 PAL questionnaire (C15 PAL). Patients' responses to the QLQ questions will be scored and converted to a numeric scale 1-4, where 1=none and 4=very much, using the standard algorithms provided by EORTC
Measured: Collected every fourth month throughout follow-up from randomization to 36 months of follow-up or until death of any cause, which ever comes first
Patient reported outcome, PRO
PRO will be evaluated using a study specific self-assessment questionnaire (PRO_GI-GU) based on the functional scale for urinary problems in patients without urostomy from EORTC QLQ - BLM30 (question 31-37) by the European Organisation for Research and Treatment of Cancer (EORTC) and the functional scale for bowel bothers from the Prostate Cancer Symptom Scale (PCSS) question 21-35,50 (ver. 1, 2013) © Fransson \& Widmark, Umeå, Sweden.
The patients' responses are converted to a numeric 0-10 scale, where 0 = none and 10 = very much, using the standard algorithms provided by EORTC and Fransson \& Widmark(PMID:33444529).
Measured: Collected at every follow up (month 1, 2 and thereafter every 4th month from randomization) until last follow-up visit at 36 months or until death of any cause, which ever comes first
Early adverse events /late adverse event
Differences between the arms in severity and frequency of reported early (within 90 days of EoRT) and late adverse events (after three months of EoRT) according to specified modules from CTCAE v5.0)
Measured: Collected at every follow up (month 1, 2 and thereafter every 4th month from randomization) until last follow-up visit at 36 months or until death of any cause, which ever comes first
Adverse event of special interest, AESI:
Differences between the arms in reporting of symptoms associated with tumour progression, specifically:
Palliative RT Blood transfusion Surgical intervention due to local progression (TURB) Hospitalisation due to bladder tumour Urinary catheter placement (urinary, suprapubic, or nephrostomy)
Measured: Collected throughout follow-up for a minimum of 36 months or until death of any cause, which ever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start3 Jun 2026
- Primary completionJun 2032 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer (BC)Studies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Västerbotten County Council, Sweden
- Responsible party
- Principal investigator, Karin Soderkvist, Umeå University
- Investigators
- Karin Söderkvist, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524426
- Sponsor's protocol ID
- 2024-02857-01
- Acronym
- LORUP
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study collects sensitive health information and no compliant, consented mechanism for sharing individual-level data has been established for this randomized controlled trial.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment; a Prospective Randomized Phase III Trial.
- ClinicalTrials.gov ID
- NCT07524426
- Acronym / sponsor ID
- LORUP / 2024-02857-01
- Conditions
- Bladder Cancer (BC)
- Keywords
- LORUP, Bladder cancer, local radiotherapy, adaptive radiotherapy, Patient Reported Outcomes, Overall survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Västerbotten County Council, Sweden
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 13 Apr 2026 (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.
The goal of this clinical trial is to improve the quality of life and prolong survival in bladder cancer patients unfit for curative treatment. The trial will compare the survival and symptoms of patients randomized to either local radiotherapy in addition to standard of care or standard of care alone.
Using modern radiotherapy techniques, including hypofractionation and image-guided treatment adaptation, the aim is to deliver a well-tolerated, time-efficient, and effective treatment strategy for these patients.
The trial collaborates with two ongoing exploratory biomarker studies collecting and analyzing potential biomarkers in urothelial bladder cancer. The hope is to provide biomarkers for prognosis and treatment response which is essential to ensure bladder cancer patients individualized treatment in the future, like those with breast and prostate cancer.
Detailed description
Around 700 individuals in Sweden are diagnosed each year with muscle-invasive bladder cancer (MIBC), and a similar number die annually from the disease (SVF RCC 2023). With a median age at diagnosis approaching 76 years (Swedish National Quality Registry for Urothelial Carcinoma), the incidence is expected to rise as the population ages.
Due to advanced age and comorbidity, many patients are not eligible for the demanding multimodal treatments used with curative intent. Recently introduced systemic therapies for palliation, such as antibody-drug conjugates and immunotherapy, also require a WHO performance status <2 and regular hospital-based administration. Consequently, up to 30% of patients receive no tumor-directed therapy at diagnosis (Swedish National Quality Registry for Urothelial Carcinoma).
Without treatment, MIBC often progresses rapidly, with a median overall survival of approximately 12 months in this cohort. Symptom burden is substantial, commonly involving pain, bleeding, and urinary tract obstruction, which frequently require repeated hospital admissions late in the disease trajectory.
Radiation therapy (RT) is an established curative modality in bladder cancer and is well documented for symptom palliation. In other malignancies, such as prostate cancer, limited radiation doses have been shown to prolong survival and reduce the development of distressing symptoms. Although some studies indicate similar benefits in bladder cancer, a clear survival effect has not been demonstrated, representing an important knowledge gap in the management of a common cancer type.
The LORUP project builds on existing translational research infrastructures to address this gap. Its aim is to develop a treatment strategy for MIBC patients unfit for curative therapy, focused on improving quality of life by reducing symptom burden and potentially prolonging survival, while maintaining a low treatment burden and minimal side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - RT and SoC | Experimental | Radiation: Local hypo fractionated adaptive radiotherapy and Standard of CareLocal hypo fractionated adaptive radiotherapy to the bladder, 7 Gy in 3 fractions delivered every other day (eod) prescribed in addition to standard of care. |
| Arm B - SoC | Active comparator | Other: Standard of Care (Investigator Choice)Standard of care. All applicable palliative treatments, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Oral and written consent
- Histologically confirmed MIBC with urothelial component
- Male or female participants ≥ 18 years old
- Deemed not to benefit from curative treatment at a multidisciplinary tumour conference (MDT) or having declined curative treatment of their own accord.
Key exclusion criteria (6 listed)
- Clinical Fragility Scale score ≥8
- Previous pelvic RT with significant overlap
- Visceral or bone metastases on CT scan
- Multiple (>3) lymph node metastases with a measurement of >2 cm on CT scan
- Planed for systemic treatment at the time of inclusion.
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 |
|---|---|---|
| Local hypo fractionated adaptive radiotherapy and Standard of CarePatients randomized to the radiotherapy (RT) arm will receive external beam radiotherapy to the whole urinary bladder as well as Standard of Care. Intensity-modulated Radiotherapy will be delivered using an adaptive treatment strategy, permitting either: * Plan-of-the-day (PoD) adaptive radiotherapy using a predefined library of plans, or * Online adaptive radiotherapy (oART) with daily re-contouring and re-optimisation to the anatomy of the day. The choice of adaptive strategy (PoD vs oART) and imaging modality (CBCT- or MR-based) is at institutional discretion, provided all protocol-specified target coverage objectives and organ-at-risk (OAR) constraints are met. The prescribed dose is 21 Gy in 3 fractions of 7 Gy, delivered every other day. | Radiation | Arm A - RT and SoC |
| Standard of Care (Investigator Choice)All applicable palliative treatments associated with the Standard of Care, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed | Other | Arm B - SoC |
Primary outcome
Overall Survival
Time frame: From date of randomization until the date of death from any cause assessed up to a minimum of 36 months
8 secondary outcomes
Disease specific Survival
Time frame: From date of randomization until the date of death by MIBC assessed up to a minimum of 36 months
Progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to a minimum of 36 months
Radiological progression-free survival
Time frame: Time from randomization to the date of the first documented radiological progression or death, whichever comes first, assessed up to a minimum of 36 months
Start of systemic anti-tumour treatment
Time frame: Time from randomization to start of systemic anti-tumour treatment assessed up to a minimum of 36 months
Health related quality of life, HRQoL
Time frame: Collected every fourth month throughout follow-up from randomization to 36 months of follow-up or until death of any cause, which ever comes first
Patient reported outcome, PRO
Time frame: Collected at every follow up (month 1, 2 and thereafter every 4th month from randomization) until last follow-up visit at 36 months or until death of any cause, which ever comes first
Early adverse events /late adverse event
Time frame: Collected at every follow up (month 1, 2 and thereafter every 4th month from randomization) until last follow-up visit at 36 months or until death of any cause, which ever comes first
Adverse event of special interest, AESI:
Time frame: Collected throughout follow-up for a minimum of 36 months or until death of any cause, which ever comes first
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 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study collects sensitive health information and no compliant, consented mechanism for sharing individual-level data has been established for this randomized controlled trial.
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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.
Karin Söderkvist, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bladder Cancer (BC), run by Umeå University at 1 site in Sweden.
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 4 inclusion and 6 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 Jun 2026. 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 Sweden. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of randomization until the date of death from any cause assessed up to a minimum of 36 months). 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 Jun 2026.