Trial Outcomes & Findings for Proton Radiotherapy for Stage I, IIA, and IIB Seminoma (NCT NCT01557790)

NCT ID: NCT01557790

Last Updated: 2020-04-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2020-04-13

Participant Flow

Participant milestones

Measure	Proton RT Subjects receive proton radiation for seminoma Proton Radiation Therapy
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Radiotherapy for Stage I, IIA, and IIB Seminoma

Baseline characteristics by cohort

Measure	Proton RT n=5 Participants Subjects receive proton radiation for seminoma Proton Radiation Therapy
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	36.86 years STANDARD_DEVIATION 13.64 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	5 participants n=93 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Proton RT n=5 Participants Subjects receive proton radiation for seminoma Proton Radiation Therapy
Number of Serious Adverse Events	0 Participants

Adverse Events

Proton RT

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Proton RT n=5 participants at risk Subjects receive proton radiation for seminoma Proton Radiation Therapy
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Number of events 1 • 5 years
Metabolism and nutrition disorders Anorexia	20.0% 1/5 • Number of events 1 • 5 years
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Number of events 1 • 5 years
Gastrointestinal disorders Constipation	60.0% 3/5 • Number of events 3 • 5 years
Injury, poisoning and procedural complications Dermatitis radiation	80.0% 4/5 • Number of events 4 • 5 years
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Number of events 2 • 5 years
Gastrointestinal disorders Dyspepsia	20.0% 1/5 • Number of events 1 • 5 years
Skin and subcutaneous tissue disorders Erythema multiforme	20.0% 1/5 • Number of events 1 • 5 years
General disorders Fatigue	60.0% 3/5 • Number of events 4 • 5 years
Gastrointestinal disorders Other Gastrointestinal disorders	20.0% 1/5 • Number of events 1 • 5 years
Vascular disorders Hypertension	20.0% 1/5 • Number of events 5 • 5 years
Gastrointestinal disorders Nausea	100.0% 5/5 • Number of events 8 • 5 years
Social circumstances Work Stress	20.0% 1/5 • Number of events 1 • 5 years
Reproductive system and breast disorders Testicular pain	20.0% 1/5 • Number of events 1 • 5 years
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • 5 years
Investigations Weight gain	20.0% 1/5 • Number of events 1 • 5 years
Investigations Weight loss	20.0% 1/5 • Number of events 1 • 5 years

Additional Information

Justin E. Bekelman, MD

University of Pennsylvania

Phone: (215)662-7292

Email: bekelman@xrt.upenn.edu

Results disclosure agreements

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