Muscle-Invasive Bladder CarcinomaARTIA-VesicaNCT05295992
Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
A study testing Varian Ethos Adaptive Radiation Therapy in people with Muscle-Invasive Bladder Carcinoma, run by Varian, a Siemens Healthineers Company at 1 site in Denmark.
Trial summary
This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- What is being tested?
- Varian Ethos Adaptive Radiation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2022to Mar 2027
- 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
- Histologically proven bladder cancer
- Urothelial carcinoma
- Age ≥ 18 years
- Stage T1b-T4AN0M0
- TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
- Suitable for radiotherapy
Show all 18Show fewer
- ECOG/WHO performance status 0-2
- Written informed consent
- For Cohort B, participant's must have normal organ and marrow function as defined below:
- leukocytes ≥2,500/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- hemoglobin ≥9 g/dL
- total bilirubin ≤ 1,5 ULN
- AST(SGOT)/ALT(SGPT) ≤3 × ULN
- alkaline phosphatase ≤2.5 × ULN
- creatinine clearance <25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance <50 ml/min.
- INR and aPTT £1.5 ULN
Who cannot join
- Prior pelvic radiation therapy
- Inability to comply with the protocol
- Presence of a hip prothesis
- Grade 2 or greater baseline diarrhea
- Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)
This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Being tested
- Varian Ethos Adaptive Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varian Ethos Adaptive Radiation TherapyDevice
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
| Study group | Role | What they receive |
|---|---|---|
| Daily Adaptive External Beam Radiation Therapy | Experimental | Daily adaptive radiation therapy delivered with Varian Ethos treatment system. Receives: Device: Varian Ethos Adaptive Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Rate CTCAE GI Toxicity
Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea
Measured: Start of radiotherapy to 3 months after end of radiotherapy
Secondary outcomes (12)
All Early CTCAE Treatment Related Toxicities
All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity
Measured: From start of radiotherapy through 3 months after end of radiotherapy
All Late CTCAE Treatment Related Toxicities
All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above
Measured: From 3 months after end of radiotherapy through 2 years follow-up
Patient Reported Outcomes (PRO)
Collection of NCI PRO-CTCAE questionnaire
Measured: Baseline through 2 year follow-up
EORTC Quality of Life Assessment
Collection of EORTC QLQ C30
Measured: Baseline through 2 year follow-up
EuroQol Quality of Life Assessment
Collection EQ-5D-5L questionnaires
Measured: Baseline through 2 year follow-up
Local Progression Free Survival
Local progression free survival
Measured: From time of inclusion to local progression, assessed up to 24 months post treatment
Local Control
Local control (freedom from local progression)
Measured: At 12 and 24 months
Progression Free Survival
Progression free survival (from time of inclusion to disease progression)
Measured: From time of inclusion to disease progression, assessed up to 24 months post treatment
Overall Survival
Overall survival
Measured: From time of inclusion to death from any cause, assessed up to 24 months post treatment
Disease Free Survival
Disease Free Survival
Measured: From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment
Treatment Related Hospitalization
Hospitalization due to adaptive radiation therapy treatment related toxicity
Measured: From of start of radiation therapy through 2 year follow-up
Workflow Feasibility
Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT
Measured: From start of radiation therapy through end of external beam treatment (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start15 Mar 2022
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Katrine Storm, MD, Principal investigator, Herlev Hospital, Copenhagen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295992
- Sponsor's protocol ID
- VAR-2021-06
- Acronym
- ARTIA-Vesica
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)
- ClinicalTrials.gov ID
- NCT05295992
- Acronym / sponsor ID
- ARTIA-Vesica / VAR-2021-06
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Mar 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.
This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily Adaptive External Beam Radiation Therapy | Experimental | Device: Varian Ethos Adaptive Radiation TherapyDaily adaptive radiation therapy delivered with Varian Ethos treatment system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically proven bladder cancer
- Urothelial carcinoma
- Age ≥ 18 years
- Stage T1b-T4AN0M0
- TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
Key exclusion criteria (5 listed)
- Prior pelvic radiation therapy
- Inability to comply with the protocol
- Presence of a hip prothesis
- Grade 2 or greater baseline diarrhea
- Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
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 |
|---|---|---|
| Varian Ethos Adaptive Radiation TherapyDaily adaptive external beam radiation therapy delivered on Varian Ethos treatment system. | Device | Daily Adaptive External Beam Radiation Therapy |
Primary outcome
Early Rate CTCAE GI Toxicity
Time frame: Start of radiotherapy to 3 months after end of radiotherapy
Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea
12 secondary outcomes
All Early CTCAE Treatment Related Toxicities
Time frame: From start of radiotherapy through 3 months after end of radiotherapy
All Late CTCAE Treatment Related Toxicities
Time frame: From 3 months after end of radiotherapy through 2 years follow-up
Patient Reported Outcomes (PRO)
Time frame: Baseline through 2 year follow-up
EORTC Quality of Life Assessment
Time frame: Baseline through 2 year follow-up
EuroQol Quality of Life Assessment
Time frame: Baseline through 2 year follow-up
Local Progression Free Survival
Time frame: From time of inclusion to local progression, assessed up to 24 months post treatment
Local Control
Time frame: At 12 and 24 months
Progression Free Survival
Time frame: From time of inclusion to disease progression, assessed up to 24 months post treatment
Overall Survival
Time frame: From time of inclusion to death from any cause, assessed up to 24 months post treatment
Disease Free Survival
Time frame: From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment
Treatment Related Hospitalization
Time frame: From of start of radiation therapy through 2 year follow-up
Workflow Feasibility
Time frame: From start of radiation therapy through end of external beam treatment (approximately 6 weeks)
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 6 Mar 2026.
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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. This study is not recruiting at the moment.
Katrine Storm, MD principal investigator
Herlev Hospital, Copenhagen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varian Ethos Adaptive Radiation Therapy in people with Muscle-Invasive Bladder Carcinoma, run by Varian, a Siemens Healthineers Company at 1 site in Denmark.
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 18 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 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 Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Rate CTCAE GI Toxicity (time frame: Start of radiotherapy to 3 months after end of radiotherapy). 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 6 Mar 2026.