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personalized ultrafractionated stereotactic ablative radiotherapy for Bladder Cancer (CIRTiN-BC Trial)

N/A
Waitlist Available
Led By Solomon L Woldu, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Appropriate candidate for stereotactic ablative radiotherapy, as determined by the treating radiation oncologist.
patient staged with bulky cN+ disease as defined above, medically ineligible to receive cisplatin-based chemotherapy, with PD-L1 positive tumor (according to methodology described in the FDA approval label for the respective ICI agent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

CIRTiN-BC Trial Summary

This trial is testing a new type of radiation therapy to see if it's feasible and effective for patients with bladder cancer who are unable to receive or respond to chemotherapy.

Eligible Conditions
  • Bladder Cancer

CIRTiN-BC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your doctor believes that you are a suitable candidate for a specific type of radiation treatment called stereotactic ablative radiotherapy.
Select...
You have a large amount of lymph node involvement that cannot be treated with cisplatin-based chemotherapy. Your tumor also has a positive PD-L1 status, which is determined by a specific method mentioned in the FDA label for the immunotherapy agent.
Select...
You have a large amount of cancer in your lymph nodes that did not go away completely after one or two cycles of chemotherapy. The chemotherapy had to be stopped because you couldn't tolerate it well.

CIRTiN-BC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Protocol Completion
Secondary outcome measures
Progression-free Survival
Other outcome measures
Major Complication Rate
Pathologic Complete Nodal Response
Pathologic Complete Response
+4 more

CIRTiN-BC Trial Design

1Treatment groups
Experimental Treatment
Group I: PULSARExperimental Treatment1 Intervention
Eligible patients will receive next-generation stereotactic radiotherapy (PULSAR) 30-36 Gy in 3 fractions to the bladder and targetable, pathologically enlarged lymph nodes

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,098 Total Patients Enrolled
Solomon L Woldu, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

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

Are there any potential dangers associated with personalized ultrafractionated stereotactic ablative radiotherapy?

"While there is some evidence backing the safety of personalized ultrafractionated stereotactic ablative radiotherapy, it remains unproven in terms of efficacy. Consequently, our team has given it a 2."

Answered by AI

Are there any current openings for new participants in this trial?

"That is correct, the trial is still actively recruiting patients according to the most recent update on clinicaltrials.gov from February 24th, 2022. This study was first posted on September 6th, 2021 and is looking for 27 participants total at 1 site."

Answered by AI

How many people can take part in this experiment?

"Per the information available on clinicaltrials.gov, this trial is still recruiting patients. The listing for the study was first created on September 6th, 2021 and last updated February 24th, 2022. So far, only 27 of the needed participants have been recruited from a single site."

Answered by AI
~0 spots leftby Mar 2025