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

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ClinicalTrials.gov Identifier: NCT01151761
Recruitment Status : Terminated (Poor accrual)
First Posted : June 28, 2010
Results First Posted : May 26, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cholangiocarcinoma
Hepatobiliary Neoplasm
Liver Cancer
Bile Duct Cancer
Cancer of Gallbladder
Interventions Procedure: Stereotactic Body Radiotherapy
Drug: Gemcitabine
Drug: Cisplatin
Drug: Carboplatin
Drug: Capecitabine
Drug: 5FU
Procedure: Liver transplantation
Enrollment 2
Recruitment Details The location is the Stanford Cancer Center. The study was open to accrual 1/18/2011. The study closed on 9/28/2012.
Pre-assignment Details  
Arm/Group Title SBRT, Chemotherapy and Liver Transplantation
Hide Arm/Group Description 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
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title SBRT, Chemotherapy and Liver Transplantation
Hide Arm/Group Description 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 Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
64.5  (9.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Progression-free Survival at 12 Months
Hide Description Progression free survival is defined to be the time to progression of disease or death.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SBRT and Chemo
Comments The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter months
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
7 to 10
Estimation Comments There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.
2.Secondary Outcome
Title Pathologic Complete Response Rate
Hide Description Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Serum CA 19-9 Levels
Hide Description Initial level of Cancer antigen 19-9
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: U/ml
3329.1
(62.2 to 6596)
4.Secondary Outcome
Title Overall Survival at 12 Months
Hide Description the estimated probability for the percentage of participants with overall survival at 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were only two patients analyzed. Please take that under advisement when looking at the results.
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: probability
0
5.Secondary Outcome
Title Liver Transplant Rate
Hide Description The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Freedom From Local Progression at 12 Months
Hide Description the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Neither of the two patients that participated in the study had a local recurrence prior to dying.
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of patients
0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SBRT and Chemo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion of participants
Estimated Value 0
Estimation Comments None of the two patients who participated had a local recurrence before they died.
7.Secondary Outcome
Title Liver Transplant Conversion Rate
Hide Description The ability to successfully perform liver transplant among patients who initially have tumor >3 cm
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
8.Secondary Outcome
Title Median Time to Overall Survival
Hide Description The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SBRT and Chemo
Hide Arm/Group Description:
The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
Overall Number of Participants Analyzed 2
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(7 to 10)
Time Frame The entire period of the study, 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SBRT, Chemotherapy and Liver Transplantation
Hide Arm/Group Description 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
All-Cause Mortality
SBRT, Chemotherapy and Liver Transplantation
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
SBRT, Chemotherapy and Liver Transplantation
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Hepatobiliary disorders   
Hepatic failure (encephalopathy)  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE V4
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SBRT, Chemotherapy and Liver Transplantation
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Chang
Organization: Stanford University Cancer Center
Phone: 650-724-3547
EMail: dtchang@stanford.edu
Layout table for additonal information
Responsible Party: Daniel T. Chang, Stanford University
ClinicalTrials.gov Identifier: NCT01151761    
Other Study ID Numbers: HEP0032
HEP0032 ( Other Identifier: Stanford University )
First Submitted: June 15, 2010
First Posted: June 28, 2010
Results First Submitted: July 3, 2013
Results First Posted: May 26, 2016
Last Update Posted: July 29, 2016