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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 24 months after completion of chemoradiotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 months after completion of chemoradiotherapy
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 moreOther 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
Eligibility Criteria:
This trial includes the following eligibility 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 am not pregnant or nursing and have a negative pregnancy test.My blood tests are within normal ranges required for the study.I am 18 years old or older.I had surgery to remove lymph nodes in my pelvis or near my aorta before starting chemoradiation.I have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's Disease.My bladder cancer is at a specific stage and has not spread to lymph nodes or other parts.My pelvic nodes are cancer-free, confirmed by scans or biopsies.If you have artificial hips in both of your hips, you cannot participate. However, if you have an artificial hip in one hip and a special CT scan shows your bladder and bowel clearly, you may be able to participate. If the CT scan doesn't show your bladder and bowel clearly, you cannot participate.I've been cancer-free for 2 years, except for non-melanoma skin cancer or non-muscle invasive bladder cancer.I've had radiation or chemo for bladder cancer but finished any bladder-specific treatments over 3 months ago.I have had cancer treatment like chemotherapy within the last 3 years.I have an active HIV infection.I have swelling in both kidneys or widespread early-stage bladder cancer.I have moderate to severe GI symptoms or severe GU conditions.I have active tuberculosis.I can care for myself but may not be able to do active work.I have had surgery to remove all or part of my bladder.I have a serious health condition that prevents me from receiving radiation or chemotherapy.I do not have scleroderma or other symptomatic autoimmune diseases, nor am I on biologic therapies for them.I had surgery to remove bladder tumors less than 70 days ago.My cancer is classified as cT4b or T4.I have had a bone marrow or solid organ transplant in the past.My cancer has spread to lymph nodes larger than 1 cm.I am scheduled for pelvic radiation and chemotherapy to try to cure my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Daily Adaptive External Beam Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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