Trial Outcomes & Findings for Proton Radiotherapy for Extremity Soft Tissue Sarcoma (NCT NCT01561495)
NCT ID: NCT01561495
Last Updated: 2019-12-06
Results Overview
Given this is initially a feasibility study- the primary measure is number of AEs (Adverse Events).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
4 years
Results posted on
2019-12-06
Participant Flow
Participant milestones
| Measure |
All Study Participants
All study participants received proton radiotherapy.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proton Radiotherapy for Extremity Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
All Study Participants
n=1 Participants
All study participants received proton radiotherapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 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
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Investigator and study team are unreachable after having left Penn despite multiple efforts to contact for more information- as such no data is available to present
Given this is initially a feasibility study- the primary measure is number of AEs (Adverse Events).
Outcome measures
Outcome data not reported
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place