Trial Outcomes & Findings for Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation (NCT NCT01151761)

Results Overview

Progression free survival is defined to be the time to progression of disease or death.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

12 months

Results posted on

2016-07-29

Participant Flow

The location is the Stanford Cancer Center. The study was open to accrual 1/18/2011. The study closed on 9/28/2012.

Participant milestones

Participant milestones
Measure	SBRT, Chemotherapy and Liver Transplantation The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT, Chemotherapy and Liver Transplantation n=2 Participants The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
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	64.5 years STANDARD_DEVIATION 9.19 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Progression free survival is defined to be the time to progression of disease or death.

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Progression-free Survival at 12 Months	0 participants

SECONDARY outcome

Timeframe: 12 months

Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Pathologic Complete Response Rate	0 participants

SECONDARY outcome

Timeframe: 12 months

Initial level of Cancer antigen 19-9

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Serum CA 19-9 Levels	3329.1 U/ml Interval 62.2 to 6596.0

SECONDARY outcome

Timeframe: 12 months

Population: There were only two patients analyzed. Please take that under advisement when looking at the results.

the estimated probability for the percentage of participants with overall survival at 12 months.

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Survival at 12 Months	0 probability

SECONDARY outcome

Timeframe: 12 months

The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Liver Transplant Rate	0 participants

SECONDARY outcome

Timeframe: 12 months

Population: Neither of the two patients that participated in the study had a local recurrence prior to dying.

the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Freedom From Local Progression at 12 Months	0 percentage of patients

SECONDARY outcome

Timeframe: 12 months

The ability to successfully perform liver transplant among patients who initially have tumor \>3 cm

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Liver Transplant Conversion Rate	0 participants

SECONDARY outcome

Timeframe: 18 months

The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.

Outcome measures

Outcome measures
Measure	SBRT and Chemo n=2 Participants The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Median Time to Overall Survival	8.5 months Interval 7.0 to 10.0

Adverse Events

SBRT, Chemotherapy and Liver Transplantation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SBRT, Chemotherapy and Liver Transplantation n=2 participants at risk The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
Hepatobiliary disorders Hepatic failure (encephalopathy)	50.0% 1/2 • Number of events 1 • The entire period of the study, 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Chang

Stanford University Cancer Center

Phone: 650-724-3547

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place