Trial Outcomes & Findings for Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery (NCT NCT02738606)
NCT ID: NCT02738606
Last Updated: 2026-02-17
Results Overview
The survival subjects were monitored with protocol defined period --- 3 years after enrollment. Survival counts each Arm (percent of survival rate) and p value of Chi-square test for survival rate comparison are shown.
TERMINATED
PHASE2
29 participants
From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 months
2026-02-17
Participant Flow
29 patients were enrolled during 9/23/2016-8/29/2025 with 4 patient removed from study due to screen failure or withdrawal consent.
8 patients were actual Arm-1 (surgery group): 5 randomly assigned as surgery; 3 randomly assigned as non-surgery but had surgery. 17 patients were actual Arm-2 (non-surgery): 14 randomly assigned as non-surgery; 3 randomly assigned as surgery but canceled.
Participant milestones
| Measure |
Arm 1: Surgery Arm
Arm-1=Liver resection, plus Chemotherapy at discretion of treating oncologist.
|
Arm 2: Non Surgery Arm
Arm-2=Control group=Chemotherapy at discretion of treating oncologist.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
17
|
|
Overall Study
COMPLETED
|
8
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm 1: Surgery Arm
n=8 Participants
Arm-1=Liver resection, plus Chemotherapy at discretion of treating oncologist.
|
Arm 2: Non Surgery Arm
n=17 Participants
Arm-2=Control group=Chemotherapy at discretion of treating oncologist.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=25 Participants
|
15 Participants
n=20 Participants
|
22 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=25 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=25 Participants
|
11 Participants
n=20 Participants
|
14 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=25 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=25 Participants
|
14 Participants
n=20 Participants
|
20 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=25 Participants
|
14 Participants
n=20 Participants
|
19 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=25 Participants
|
17 participants
n=20 Participants
|
25 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 monthsThe survival subjects were monitored with protocol defined period --- 3 years after enrollment. Survival counts each Arm (percent of survival rate) and p value of Chi-square test for survival rate comparison are shown.
Outcome measures
| Measure |
Arm 1: Surgery Arm
n=8 Participants
Arm-1=Liver resection, plus Chemotherapy at discretion of treating oncologist.
|
Arm 2: Non Surgery Arm
n=17 Participants
Arm-2=Control group=Chemotherapy at discretion of treating oncologist.
|
|---|---|---|
|
Number of Participants With Survival
|
5 Participants
|
5 Participants
|
Adverse Events
Arm 1: Surgery Arm
Arm 2: Non Surgery Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yun Shin Chun
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place