Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach (ARTIA-Vesica)

March 4, 2026 updated by: Varian, a Siemens Healthineers Company

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Herlev, Denmark, DK-2730
        • Herlev and Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically proven bladder cancer
  2. Urothelial carcinoma
  3. Age ≥ 18 years
  4. Stage T1b-T4AN0M0
  5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
  6. Suitable for radiotherapy
  7. ECOG/WHO performance status 0-2
  8. Written informed consent

  9. 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

Exclusion Criteria:

  1. Prior pelvic radiation therapy
  2. Inability to comply with the protocol
  3. Presence of a hip prothesis
  4. Grade 2 or greater baseline diarrhea
  5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Daily Adaptive External Beam Radiation Therapy
Daily adaptive radiation therapy delivered with Varian Ethos treatment system.
Device: Varian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Start of radiotherapy to 3 months after end of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All Early CTCAE Treatment Related Toxicities
Time Frame: From start of radiotherapy through 3 months after end of radiotherapy
All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity
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
All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above
From 3 months after end of radiotherapy through 2 years follow-up
Patient Reported Outcomes (PRO)
Time Frame: Baseline through 2 year follow-up
Collection of NCI PRO-CTCAE questionnaire
Baseline through 2 year follow-up
EORTC Quality of Life Assessment
Time Frame: Baseline through 2 year follow-up
Collection of EORTC QLQ C30
Baseline through 2 year follow-up
EuroQol Quality of Life Assessment
Time Frame: Baseline through 2 year follow-up
Collection EQ-5D-5L questionnaires
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 progression free survival
From time of inclusion to local progression, assessed up to 24 months post treatment
Local Control
Time Frame: At 12 and 24 months
Local control (freedom from local progression)
At 12 and 24 months
Progression Free Survival
Time Frame: From time of inclusion to disease progression, assessed up to 24 months post treatment
Progression free survival (from time of inclusion to disease progression)
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
Overall survival
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
Disease Free Survival
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
Hospitalization due to adaptive radiation therapy treatment related toxicity
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)
Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT
From start of radiation therapy through end of external beam treatment (approximately 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Varian, a Siemens Healthineers Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rigshospitalet, Denmark
Herlev Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katrine Storm, MD, Herlev Hospital, Copenhagen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAR-2021-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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