Trial Outcomes & Findings for Radiation Therapy vs. Observation Following Gemcitabine and Cisplatin for Inoperable Localized Liver Cancer (NCT NCT02200042)
NCT ID: NCT02200042
Last Updated: 2019-08-28
Results Overview
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
TERMINATED
PHASE3
1 participants
From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.
2019-08-28
Participant Flow
Participant milestones
| Measure |
Radiation Therapy
Liver-directed radiation therapy
Radiation Therapy: Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days.
|
Observation
No radiation therapy
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Radiation Therapy
Liver-directed radiation therapy
Radiation Therapy: Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days.
|
Observation
No radiation therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Radiation Therapy vs. Observation Following Gemcitabine and Cisplatin for Inoperable Localized Liver Cancer
Baseline characteristics by cohort
| Measure |
Radiation Therapy
Liver-directed radiation therapy
Radiation Therapy: Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days.
|
Observation
n=1 Participants
No radiation therapy
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.Population: No patients have outcome data.
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.Population: No patients have outcome data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.Population: No patients have outcome data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.Population: No patients have outcome data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.Population: No patients have outcome data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.Population: No patients have outcome data.
Outcome measures
Outcome data not reported
Adverse Events
Radiation Therapy
Observation
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 PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER