Short-Course Radiation + Chemotherapy for Bladder Cancer

(ARTIA-Bladder Trial)

Overseen by Brian Baumann, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Varian, a Siemens Healthineers Company

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Brian Baumann, MD

Principal Investigator

Springfield Clinic

Eligibility Criteria

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.

Inclusion Criteria

Ability to complete required patient questionnaires

I am not pregnant or nursing and have a negative pregnancy test.

My blood tests are within normal ranges required for the study.

Exclusion Criteria

I cannot lie still for 30 minutes due to urinary issues or other health problems.

I have a history or current diagnosis of bowel fistula.

I had surgery to remove lymph nodes in my pelvis or near my aorta before starting chemoradiation.

Treatment Details

Interventions

• Daily Adaptive External Beam Radiation Therapy (Radiation Therapy)

Trial Overview 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.

Participant Groups

Group I: Daily Adaptive External Beam Radiation Therapy Experimental Treatment 1 Intervention

Daily adaptive radiation therapy delivered with Varian Ethos treatment system

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials

35

Recruited

7,200+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine