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Muscle Invasive Bladder Urothelial CarcinomaARTIA-BladderNCT05700227

Daily Online Adaptive Short-Course Radiation Therapy and Concurrent Chemotherapy for Muscle-Invasive Bladder Cancer

A study testing Daily Adaptive External Beam Radiation Therapy in people with Muscle Invasive Bladder Urothelial Carcinoma, run by Varian, a Siemens Healthineers Company at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle-invasive bladder cancer will translate into a decreased rate of acute (assessed weekly during chemo-radiotherapy) grade 3 or greater gastrointestinal/genitourinary toxicity compared with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Daily Adaptive External Beam Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
2 Feb 2023to 9 May 2024
Phase
Interventional
Are there results?
None posted in the registry

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.
  • Patients must have histologically proven cT2-T4aN0M0 (AJCC v8) urothelial carcinoma of the bladder with an intact bladder. Mixed urothelial histology is permitted as long as there is some urothelial histology component and no small cell component present.
  • Patients must have undergone an attempt at maximal transurethral resection of bladder tumor (TURBT) within 70 days prior to enrollment.
  • A negative pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MRI scan, fine needle biopsy, extra peritoneal biopsy, or laparoscopic biopsy, per institutional standard of care.
  • Patients must be planning to undergo concurrent pelvic radiation and chemotherapy with curative intent.
  • ECOG performance status ≤2 (Karnofsky ≥60%).
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  • Ability to complete required patient questionnaires.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must have normal organ and marrow function as defined below, obtained within 28 days prior to enrollment:
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • hemoglobin ≥9 g/dL (can be transfused with red blood cells pre-study)
  • total bilirubin ≤1.5 × institutional upper limit of normal (ULN) unless the patient has Gilbert's syndrome who must have total bilirubin <3.0 mg/dL
  • AST(SGOT)/ALT(SGPT) ≤3 × ULN
  • alkaline phosphatase ≤2.5 × ULN
  • creatinine clearance ≥30 ml/min. We recommend avoiding cisplatin for patients with creatinine clearance <50 ml/min.
  • For the purpose of estimating the creatinine clearance, this formula may be used:
  • Estimated creatinine clearance=((140-age)×wt (kg) ×0.85 (if female))/(72 x creatinine (mg/dl) )
  • Female patients of childbearing potential (defined as having a menses at any time in the preceding 12 months) must have a negative serum pregnancy test prior to enrollment. Patients must not be pregnant or nursing because of the potential risk of injury to the fetus/child.

Who cannot join

  • Grade ≥ 2 CTCAE GI or grade ≥ 3 GU symptoms/conditions at baseline (including ongoing refractory gross hematuria post TURBT)
  • Patients with clinically involved nodes (nodes consistent morphologically with malignancy and which are greater than 1 cm on short axis on CT or MRI).
  • Patients with cT4b disease. Patients with T4 disease after 8 subjects with T4 disease have been enrolled.
  • Bilateral hydronephrosis or diffuse carcinoma in situ based on cystoscopy or biopsy. Unilateral hydronephrosis is allowed provided the patient's kidney function meets the trial criteria. Patients should be evaluated for consideration of stenting or nephrostomy tubes for moderate-to-severe unilateral hydronephrosis prior to initiation of chemo-radiotherapy.
  • Prior radiation therapy to the pelvis or abdominal cavity, prior systemic chemotherapy/systemic therapy for bladder cancer. Prior intravesical therapy (BCG, interferon, intravesical chemotherapy) is allowed provided the time interval from completion of intravesical therapy is at least 3 months.
  • Prior cystectomy or partial cystectomy.
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  • Prior malignancy (except for non-melanoma skin cancer) unless disease-free for at least 2 years. Prior non-muscle invasive bladder cancer is allowed. Patients must not have a history of urothelial carcinoma or variant histology at any site outside of the urinary bladder within the previous 24 months except Ta/T1/carcinoma in situ of the upper urinary tract (including renal pelvis and ureter) provided the patient has undergone complete nephroureterectomy and still meets trial eligibility for creatinine clearance. Patients with localized prostate cancer who are being followed on an active surveillance program are also eligible.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study or induction chemotherapy prior to the start of concurrent chemo-radiotherapy
  • Serious medical comorbidities precluding RT and/or chemotherapy (e.g., active uncontrolled infection )
  • Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease.
  • Patients with scleroderma. Patients who are symptomatic from other auto-immune diseases or patients on biologic therapies for auto-immune diseases are also excluded.
  • Patients with active tuberculosis (TB).
  • Patients who are pregnant or actively breastfeeding and who do not agree to discontinue breastfeeding before the initiation of radiation treatment planning or bladder cancer therapy.
  • Women of childbearing potential and men who do not agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment, and for 5 months after the last study treatment.
  • Patients with a prior known history or current diagnosis of bowel fistula.
  • Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned chemoradiation therapy.
  • Patients with known active infection of HIV.
  • Patients with bilateral hip prosthetics. Select patients with unilateral hip prosthetics are eligible provided that a diagnostic CT scan permits good visualization of the entire bladder and adjacent bowel. Patients with poor visualization of the bladder/bowel on diagnostic CT scan prior to simulation should not be enrolled.
  • Patients with poorly visualized bladder and bowel on diagnostic CT [either due to body habitus or artifact (motion, artifact, etc.)] are excluded.
  • Patients who in the opinion of the investigator are not able to spend 30 minutes lying on the radiation therapy treatment couch due to significant urinary frequency/urgency or other co-morbidities.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University, St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Daily Online Adaptive Short-Course Radiation Therapy and Concurrent Chemotherapy for Muscle-Invasive Bladder Cancer: A Prospective Trial of an Individualized Approach for Reducing Bowel and Bladder Toxicity (ARTIA-Bladder)

This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle-invasive bladder cancer will translate into a decreased rate of acute (assessed weekly during chemo-radiotherapy) grade 3 or greater gastrointestinal/genitourinary toxicity compared with the historically reported rate for non-adaptive radiation therapy. The Common Terminology Criteria for Adverse Events (CTCAE) version 5 assessment tool will be utilized.

Being tested
Daily Adaptive External Beam Radiation Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily Adaptive External Beam Radiation TherapyRadiation

    Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Study groups in NCT05700227
Study groupRoleWhat they receive
Daily Adaptive External Beam Radiation TherapyExperimentalDaily adaptive radiation therapy delivered with Varian Ethos treatment system
Receives: Radiation: Daily Adaptive External Beam Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute GI/GU Toxicity

    Acute gastrointestinal and genitourinary CTCAE v5 grade 3 or higher toxicity

    Measured: Assessed during the 4 weeks of external beam radiation therapy

Secondary outcomes (13)

  1. Loco-regional Tumor Control

    Loco-regional bladder tumor control at 2 years. Events include histologically proven presence of muscle-invasive disease or clinical evidence of nodal disease

    Measured: From baseline to 24 months after completion of chemoradiotherapy

  2. Patient-reported Quality of Life

    Patient-reported quality of life changes during and after EBRT treatment using adaptive IMRT by the subscale EORTC QLQ-BLM30 and EPIC 26

    Measured: From baseline to 24 months after completion of chemoradiotherapy

  3. Adverse Events

    Physician reported CTCAE V5 adverse events

    Measured: From the start of external beam radiation therapy to 24 months after completion chemoradiotherapy

  4. Global Function

    Change in global function as measured with EuroQol 5 dimension 5 level (EQ-5D-5L) questionnaire. Higher scores for a given dimension indicate degraded function.

    Measured: From baseline to 24 months after completion of chemoradiotherapy

  5. Disease-free Survival

    Disease-free survival at 2 years (events include histologically proven presence of muscle-invasive disease, clinical evidence of nodal or metastatic disease, or death due to any cause)

    Measured: From the start of external beam radiation therapy to 24 months after completion chemoradiotherapy

  6. Bladder Intact Event-free Survival

    Bladder intact event-free survival at 2 years (events include histologically proven presence of muscle-invasive disease, clinical evidence of nodal or metastatic disease, radical cystectomy, or death due to any cause)

    Measured: From the start of external beam radiation therapy to 24 months after completion chemoradiotherapy

  7. Bladder-cancer Specific Mortality

    Bladder-cancer specific mortality at 2 years

    Measured: From the start of external beam radiation therapy to 24 months after completion chemoradiotherapy

  8. Overall Survival

    Overall survival at 2 years

    Measured: From the start of external beam radiation therapy to 24 months after completion chemoradiotherapy

  9. NTCP Model

    Normal tissue complication probability (NTCP) model of acute GI toxicity for hypofractionated bladder RT based on true integrated daily dose to the bowel

    Measured: Assessed during the 4 weeks of external beam radiation therapy

  10. Adaptive Workflow Feasibility

    Workflow feasibility of adaptive image guided EBRT for bladder cancer (including measuring time on table and frequency of using the adapted vs. original treatment plan for each fraction)

    Measured: Assessed during the 4 weeks of external beam radiation therapy

  11. Dosimetric Coverage

    Improvement in target coverage and/or reduction in dose to critical organs at risk compared to the non-adaptive planned dosimetry

    Measured: Assessed during the 4 weeks of external beam radiation therapy

  12. Acute GI/GU Toxicity (>75% daily adaptive sub-cohort analysis)

    Acute grade 3 or higher GI/GU CTCAE v5 toxicity rate in subjects who received 75% or more of their fractions as adaptive treatments

    Measured: Assessed during the 4 weeks of external beam radiation therapy

  13. Acute GI/GU Toxicity (partial bladder boost sub-cohort analysis)

    Acute GI/GU CTCAE v5 grade 3 or higher toxicity (assessed weekly during chemo-radiotherapy) in the cohort treated with partial bladder boost to 55 Gy

    Measured: Assessed during the 4 weeks of external beam radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start2 Feb 2023
  3. Primary completion9 May 2024
  4. Study completion9 May 2024

Why it stopped: Low enrollment

Resources

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700227
Sponsor's protocol ID
VAR-2021-05
Acronym
ARTIA-Bladder
Status last verified
Apr 2026
First submitted
17 Jan 2023
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Daily Adaptive External Beam Radiation Therapy in people with Muscle Invasive Bladder Urothelial Carcinoma, run by Varian, a Siemens Healthineers Company at 1 site in United States.

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 19 inclusion and 21 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: stopped early, as of the sponsor's last update on 21 Apr 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 United States. 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?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

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?

Acute GI/GU Toxicity (time frame: Assessed during the 4 weeks of external beam radiation therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05700227.

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 21 Apr 2026.

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