Trial Outcomes & Findings for Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura (NCT NCT00601848)
NCT ID: NCT00601848
Last Updated: 2020-11-24
Results Overview
Toxicities of PDT as defined by CTCAE v4.0
TERMINATED
PHASE2
9 participants
One year
2020-11-24
Participant Flow
Participant milestones
| Measure |
Photodynamic Therapy
PDT
chemotherapy
porfimer sodium
immunohistochemistry staining method
laboratory biomarker analysis
spectroscopy
therapeutic conventional surgery
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura
Baseline characteristics by cohort
| Measure |
Single Arm
n=9 Participants
PDT
chemotherapy
porfimer sodium
immunohistochemistry staining method
laboratory biomarker analysis
spectroscopy
therapeutic conventional surgery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Toxicities of PDT as defined by CTCAE v4.0
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 5 yearsPopulation: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Subject survival post PDT
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 5 yearsPopulation: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Amount of time from PDT to disease progression in pleura
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Amount of time from PDT to disease progression at any site in the body
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Measured uptake of PDT drug
Outcome measures
Outcome data not reported
Adverse Events
Single Arm
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