Trial Outcomes & Findings for Adjuvant Proton Therapy or IMRT for the Treatment of Bladder Cancer (NCT NCT01520038)

NCT ID: NCT01520038

Last Updated: 2019-11-26

Results Overview

Applies to Proton only

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: withion 14 days of estimated date of treatment completion
• Results posted on: 2019-11-26

Participant Flow

Participant milestones

Measure	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjuvant Proton Therapy or IMRT for the Treatment of Bladder Cancer

Baseline characteristics by cohort

Measure	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla n=2 Participants Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 12.16 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: withion 14 days of estimated date of treatment completion

Applies to Proton only

Outcome measures

Measure	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla n=2 Participants Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Number of Participants With Adverse Events	2 Participants

PRIMARY outcome

Timeframe: within 90 days of radiation therapy

Applies to Both Proton and IMRT

Outcome measures

Measure	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla n=2 Participants Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Number of Participants With Adverse Events	2 Participants

SECONDARY outcome

Timeframe: later than 90 days from start of radiation therapy

Late toxicty

Outcome measures

Measure	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla n=2 Participants Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Number of Participants With Adverse Events	2 Participants

Adverse Events

Adjuvant Radiation Therapy for the Treatment of Urothelial Bla

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla n=2 participants at risk Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
General disorders Death NOS	50.0% 1/2 • Number of events 1
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 1

Other adverse events

Measure	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla n=2 participants at risk Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Gastrointestinal disorders Abdominal distension	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Abdominal pain	100.0% 2/2 • Number of events 3
Blood and lymphatic system disorders Anemia	100.0% 2/2 • Number of events 4
Gastrointestinal disorders Bloating	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1
Investigations Creatinine increased	50.0% 1/2 • Number of events 1
Psychiatric disorders Depression	100.0% 2/2 • Number of events 2
Injury, poisoning and procedural complications Dermatitis radiation	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Diarrhea	100.0% 2/2 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Number of events 1
General disorders Fatigue	100.0% 2/2 • Number of events 4
Gastrointestinal disorders Fecal incontinence	50.0% 1/2 • Number of events 1
Vascular disorders Hot flashes	50.0% 1/2 • Number of events 1
Vascular disorders Hypertension	100.0% 2/2 • Number of events 7
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 2/2 • Number of events 2
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • Number of events 1
Investigations Lymphocyte count decreased	100.0% 2/2 • Number of events 2
Respiratory, thoracic and mediastinal disorders Nasal congestion	50.0% 1/2 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Rectal pain	50.0% 1/2 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sore throat	50.0% 1/2 • Number of events 1
Reproductive system and breast disorders Vaginal discharge	50.0% 1/2 • Number of events 1
Reproductive system and breast disorders Vaginal hemorrhage	50.0% 1/2 • Number of events 1
Investigations Weight loss	50.0% 1/2 • Number of events 1

Additional Information

John Christodouleas, MD

University of Pennsylvania

Phone: 215-662-6568

Email: christojo@uphs.upenn.edu

Results disclosure agreements

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