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Radiation Therapy

Short-Course Radiation + Chemotherapy for Bladder Cancer (ARTIA-Bladder Trial)

N/A
Recruiting
Led By Brian Baumann, MD
Research Sponsored by Varian, a Siemens Healthineers Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients of childbearing potential 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of external beam radiation therapy to 24 months after completion chemoradiotherapy
Awards & highlights

ARTIA-Bladder Trial Summary

This trial tests a new type of radiation for bladder cancer to reduce GI/genitourinary side effects. It'll use the CTCAE version 5 to assess toxicity.

Who is the study for?
Adults over 18 with muscle-invasive bladder cancer that hasn't spread (cT2-T4aN0M0), who've had a recent tumor removal attempt, can sign consent, and have normal organ/marrow function. Women must not be pregnant/nursing and negative for pregnancy. Excludes those with certain baseline symptoms, active TB/HIV/auto-immune diseases, prior pelvis/abdomen radiation or systemic chemotherapy for bladder cancer within 3 years.Check my eligibility
What is being tested?
The trial is testing if daily adaptive external beam radiation therapy alongside chemotherapy reduces severe gastrointestinal/genitourinary side effects in bladder cancer patients compared to traditional non-adaptive methods. It's a single-arm study across multiple centers using the CTCAE v5 tool weekly during treatment.See study design
What are the potential side effects?
Potential side effects include acute grade 3 or greater gastrointestinal/genitourinary toxicity such as severe digestive system issues and urinary tract problems assessed weekly during the concurrent chemo-radiotherapy phase.

ARTIA-Bladder Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or nursing and have a negative pregnancy test.
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My blood tests are within normal ranges required for the study.
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I am 18 years old or older.
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My bladder cancer is at a specific stage and has not spread to lymph nodes or other parts.
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My pelvic nodes are cancer-free, confirmed by scans or biopsies.
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I can care for myself but may not be able to do active work.
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I had surgery to remove bladder tumors less than 70 days ago.
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I am scheduled for pelvic radiation and chemotherapy to try to cure my cancer.

ARTIA-Bladder Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 months after completion of chemoradiotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 24 months after completion of chemoradiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute GI/GU Toxicity
Secondary outcome measures
Acute GI/GU Toxicity (>75% daily adaptive sub-cohort analysis)
Acute GI/GU Toxicity (partial bladder boost sub-cohort analysis)
Adaptive Workflow Feasibility
+10 more
Other outcome measures
Exploratory Translational Objective

ARTIA-Bladder Trial Design

1Treatment groups
Experimental Treatment
Group I: Daily Adaptive External Beam Radiation TherapyExperimental Treatment1 Intervention
Daily adaptive radiation therapy delivered with Varian Ethos treatment system

Find a Location

Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor
27 Previous Clinical Trials
6,967 Total Patients Enrolled
Washington University School of MedicineOTHER
1,928 Previous Clinical Trials
2,296,799 Total Patients Enrolled
Brian Baumann, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Daily Adaptive External Beam Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05700227 — N/A
Bladder Cancer Research Study Groups: Daily Adaptive External Beam Radiation Therapy
Bladder Cancer Clinical Trial 2023: Daily Adaptive External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT05700227 — N/A
Daily Adaptive External Beam Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05700227 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still opportunity for participants to be enrolled in this clinical investigation?

"As of this moment, the posted information on clinicaltrials.gov suggests that this medical research is not recruiting participants. Initially announced on February 1st 2023 and updated as recently as January 17th 2023, there are no current openings for study volunteers - though 416 other trials remain open to applicants."

Answered by AI
~72 spots leftby Feb 2025