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Trial Outcomes & Findings for Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer (NCT NCT04779489)

NCT ID: NCT04779489

Last Updated: 2024-02-06

Results Overview

proportion of patients completing PULSAR and undergoing radical cystectomy

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-02-06

Participant Flow

Participant milestones

Participant milestones
Measure
PULSAR
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
Overall Study
STARTED
1
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
PULSAR
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
Overall Study
Physician Decision
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PULSAR
n=1 Participants
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
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
Age, Categorical
>=65 years
1 Participants
n=99 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
Sex: Female, Male
Male
1 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
Race (NIH/OMB)
White
1 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
1 participants
n=99 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: 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.

proportion of patients completing PULSAR and undergoing radical cystectomy

Outcome measures

Outcome measures
Measure
PULSAR
n=1 Participants
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
Protocol Completion
1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 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.

proportion of patients without disease progression

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: 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.

patients experiencing Clavien-Dindo Grade III+ surgical complication

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of radical cystectomy

Population: 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.

patients achieving pathologic ypT0 N0 status

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of radical cystectomy

Population: 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.

patients achieving pathologic ≤ ypT1 N0 status

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of radical cystectomy

Population: 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.

patients achieving pathologic ≤ ypT2 N0 status

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of radical cystectomy

Population: 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.

patients achieving pathologic ypN0 status

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of radical cystectomy

Population: 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.

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

proportion of patients requiring procedural intervention for ureteroenteric stricture

Outcome measures

Outcome data not reported

Adverse Events

PULSAR

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
PULSAR
n=1 participants at risk
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
General disorders
Fever
100.0%
1/1 • Number of events 2 • 1 year, 5 months
Renal and urinary disorders
Pyelonephritis
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Nervous system disorders
Worsening Falling /Unsteadiness
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Gastrointestinal disorders
Abdominal distension
100.0%
1/1 • Number of events 2 • 1 year, 5 months
Gastrointestinal disorders
Intra-Abdominal Abscess
100.0%
1/1 • Number of events 1 • 1 year, 5 months

Other adverse events

Other adverse events
Measure
PULSAR
n=1 participants at risk
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
Gastrointestinal disorders
Dry Mouth
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Skin and subcutaneous tissue disorders
Dry Skin
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Endocrine disorders
Adrenocorticotropic Hormone Level <5
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Endocrine disorders
Adrenal insufficiency
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Infections and infestations
Elevated Liver Function Test
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Gastrointestinal disorders
Draining from abdomen
100.0%
1/1 • Number of events 2 • 1 year, 5 months
Reproductive system and breast disorders
Pain to testicles
100.0%
1/1 • Number of events 1 • 1 year, 5 months
Nervous system disorders
Lethargy
100.0%
1/1 • Number of events 1 • 1 year, 5 months

Additional Information

Dr. Solomon Woldu

UT Southwestern Medical Center

Phone: 214-648-9558

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place