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Effectiveness of the Combined WLI and Hyperthermia for GI Cancer Liver Metastasis

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ClinicalTrials.gov Identifier: NCT01963117
Recruitment Status : Terminated (Poor accrual)
First Posted : October 16, 2013
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hyperthermia
Intervention Radiation: Combined hyperthermia and radiation therapy
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description Combined hyperthermia and radiation therapy
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title CERT
Hide Arm/Group Description Combination treatment with transarterial chemoembolization, radiotherapy, and hyperthermia
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
HCC patients who will receive combination treatment with transarterial chemoembolization, radiotherapy, and hyperthermia
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  45.5%
>=65 years
6
  54.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
56
(35 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Korea Number Analyzed 11 participants
11
Child Pugh Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Child Pugh Class A 9
Child Pugh Class B 2
[1]
Measure Description:

Child Pugh Class A; score 5 to 6 Child Pugh Class B; score 7 to 10 Child Pugh Class Cl score 11 to 18

Total range of score is 5 to 18 with higher scores/increased scores indicate greater severity of poor liver function.

1.Primary Outcome
Title Time to Local Tumor Progression After Combined Hyperthermia and RT
Hide Description Local progression will be defined as more than 20% size increase of metastatic lesions or new metastatic lesion in liver. Time to local tumor progression will be measured from the date of RT start to the date of local progression or last follow-up visit.
Time Frame Patient will be evaluated after combined hyperthermia and RT until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 19 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent combined hyperthermia and radiation therapy
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description:
Combined hyperthermia and radiation therapy
Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: Months
18.5
(15.1 to 21.9)
2.Secondary Outcome
Title Objective Response Rate of Combined Hyperthermia and RT
Hide Description [Not Specified]
Time Frame Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description:
Combined hyperthermia and radiation therapy
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
10
3.Secondary Outcome
Title Change in the Grade of Quality of Life at 3 Months From That Before the Combined Hyperthermia and RT
Hide Description To measure the quality of life, European Organisation for Research and Treatment of Cancer (EORTC)- quality of life questionnaire (QLQ) 30 and Functional Assessment of Cancer Therapy-Hepatobiliary will be used. (grade 1 to 4, 1; not at all, 2; a little, 3; quite a bit, 4; very much)
Time Frame Quality of life will be ssessed at baseline and 3 months after combined hyperthemica and RT, data reported 3 months after combined hyperthemica and RT with grade from 1 to 4.
Hide Outcome Measure Data
Hide Analysis Population Description
European Organisation for Research and Treatment of Cancer (EORTC)- quality of life questionnaire (QLQ) 30 and Functional Assessment of Cancer Therapy-Hepatobiliary will be used from grade 1 to 4.
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description:
Combined hyperthermia and radiation therapy
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: score on a scale
-2
(-3 to 3)
4.Secondary Outcome
Title Local Tumor Progression Free Survival Rate After Combined Hyperthermia and RT
Hide Description Local progression will be defined as more than 20% size increase of metastatic lesions or new metastatic lesion in liver. Local progression free survival will be measured from the date of RT start to the date of local progression or last follow-up visit.
Time Frame Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description:
Combined hyperthermia and radiation therapy
Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: Months
18.5
(15.1 to 21.9)
5.Secondary Outcome
Title Adverse Event After Combined Hyperthermia and RT.
Hide Description All grade III or higher toxicities (repeated measure)
Time Frame Adverse event will be evaluated at 3 month. The common terminology criteria for adverse events (CTCAE) version 4.0 will be used.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description:
Combined hyperthermia and radiation therapy
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
1
6.Secondary Outcome
Title Overall Survival Rate After Combined Hyperthermia and RT
Hide Description Overall survival will be measured from the date of RT start to the date of death or last follow-up visit.
Time Frame Pathient will be evaluated at 3 month after combined hyperthermia and RT.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description:
Combined hyperthermia and radiation therapy
Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: Months
18
(15.1 to 19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combined Hypertermia and RT
Hide Arm/Group Description Combined hyperthermia and radiation therapy
All-Cause Mortality
Combined Hypertermia and RT
Affected / at Risk (%)
Total   1/11 (9.09%)    
Hide Serious Adverse Events
Combined Hypertermia and RT
Affected / at Risk (%) # Events
Total   4/11 (36.36%)    
Respiratory, thoracic and mediastinal disorders   
Death [1]  4/11 (36.36%)  5
[1]
Pneumonitis outside RT field
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combined Hypertermia and RT
Affected / at Risk (%) # Events
Total   0/11 (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: Professor
Organization: Samsung Medical Center
Phone: 82-2-3410-2612
EMail: hee.ro.park@gmail.com
Layout table for additonal information
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01963117    
Other Study ID Numbers: SMC IRB 2013-06-040
First Submitted: September 25, 2013
First Posted: October 16, 2013
Results First Submitted: September 4, 2018
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020