Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Urinary Bladder Neoplasms

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Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

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Immunomodulating Agents

Eligible patients will receive next-generation stereotactic radiotherapy (PULSAR) 30-36 Gy in 3 fractions to the bladder and targetable, pathologically enlarged lymph nodes

next-generation stereotactic ablative radiotherapy to bladder and enlarged lymph nodes

personalized ultrafractionated stereotactic ablative radiotherapy

Solomon L Woldu, MD

Clinically node positive (cN+) bladder cancer carries a poor prognosis, especially in patients who are unable to receive or fail to respond to neoadjuvant chemotherapy. Immune checkpoint inhibitor (ICI) therapy is FDA-approved in advanced bladder cancer for patients unable to receive or failing to respond to platinum-based chemotherapy. The present study seeks to determine if next-generation radiation therapy (personalized ultrafractionated stereotactic ablative radiotherapy, or PULSAR) is feasible and effective in patients receiving ICI for bulky cN+ bladder cancer.

Patients are eligible for the trial if they have bulky, clinically node-positive (cN+) bladder cancer and have either recently initiated (within ≤ 1 week) or are planned to initiate immune checkpoint inhibitor (ICI) therapy due to either 1) ineligibility for/refusal of platinum-based downstaging chemotherapy; or 2) failure to achieve a complete clinical response to platinum-based downstaging chemotherapy. Patients will initiate PULSAR treatment 1-2 weeks after initiating ICI. PULSAR will be administered in 3 fractions of 12 Gy each (36 Gy total) at 12-16 day intervals and patients will undergo radical cystectomy with bilateral extended pelvic lymph node dissection within 4-8 weeks after completion of PULSAR. ICI therapy will be administered according to the FDA-approved dosing route and schedule and will be continued during PULSAR treatments.

PULSAR treatment will be initiated 1-2 weeks after the patient is initiated on an FDA-approved ICI agent. PULSAR will be administered in 3 fractions of 12 Gy each at 12-16 day intervals. Target areas will include the region of the bladder containing the primary tumor (confirmed, if necessary, on office flexible cystoscopy at UTSW) and to up to five targetable, pathologically enlarged bulky lymph nodes (as deemed feasible by the treating radiation oncologist). Non-enlarged pelvic lymph nodes will be spared to minimize adverse effects on the tumor immune response.

Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer

Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer (CIRTiN-BC): A Phase II, Single-Arm Trial

patients experiencing Clavien-Dindo Grade III+ surgical complication

patients achieving pathologic ypT0 N0 status

patients achieving pathologic ≤ ypT1 N0 status

patients achieving pathologic ≤ ypT2 N0 status

patients achieving pathologic ypN0 status

patients with microscopic (R1) or gross (R2) residual disease

proportion of patients requiring procedural intervention for ureteroenteric stricture

proportion of patients completing PULSAR and undergoing radical cystectomy

proportion of patients without disease progression

University of Texas Southwestern Medical Center

Assistant Professor, Urology

Eligible patients will receive next-generation stereotactic radiotherapy (PULSAR) 30-36 Gy in 3 fractions to the bladder and targetable, pathologically enlarged lymph nodes

personalized ultrafractionated stereotactic ablative radiotherapy: next-generation stereotactic ablative radiotherapy to bladder and enlarged lymph nodes

PULSAR

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Solomon Woldu

One subject was enrolled and completed therapy but before the last two visits were completed, the study was terminated. Not enough data was collected to be analyzed.

Protocol Completion

One subject was enrolled and completed therapy. They study was terminated before the last two visits were completed and data could not be collected to be analyzed.

Progression-free Survival

One subject was enrolled and completed therapy. They study was terminated before the last two visits were completed. Not enough data was collected to be analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer	NCT04779489	Bladder Cancer	personalized ul...	18 Years -	University of Texas Southwestern Medical Center
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer	NCT04779489	Bladder Cancer	personalized ul...	18 Years -	University of Texas Southwestern Medical Center
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer	NCT04779489	Bladder Cancer	personalized ul...	18 Years -	University of Texas Southwestern Medical Center

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