Trial Outcomes & Findings for Effectiveness of the Combined WLI and Hyperthermia for GI Cancer Liver Metastasis (NCT NCT01963117)

NCT ID: NCT01963117

Last Updated: 2020-03-19

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 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.
• Results posted on: 2020-03-19

Participant Flow

Participant milestones

Measure	Combined Hypertermia and RT Combined hyperthermia and radiation therapy
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Combined Hypertermia and RT Combined hyperthermia and radiation therapy
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CERT n=11 Participants Combination treatment with transarterial chemoembolization, radiotherapy, and hyperthermia
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment South Korea	11 participants n=5 Participants
Child Pugh Class Child Pugh Class A	9 participants n=5 Participants
Child Pugh Class Child Pugh Class B	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Patients who underwent combined hyperthermia and radiation therapy

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.

Outcome measures

Measure	Combined Hypertermia and RT n=10 Participants Combined hyperthermia and radiation therapy
Time to Local Tumor Progression After Combined Hyperthermia and RT	18.5 Months Interval 15.1 to 21.9

SECONDARY outcome

Timeframe: Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.

Outcome measures

Measure	Combined Hypertermia and RT n=10 Participants Combined hyperthermia and radiation therapy
Objective Response Rate of Combined Hyperthermia and RT	10 participants

SECONDARY outcome

Timeframe: 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.

Population: 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.

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)

Outcome measures

Measure	Combined Hypertermia and RT n=4 Participants Combined hyperthermia and radiation therapy
Change in the Grade of Quality of Life at 3 Months From That Before the Combined Hyperthermia and RT	-2 score on a scale Interval -3.0 to 3.0

SECONDARY outcome

Timeframe: Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.

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.

Outcome measures

Measure	Combined Hypertermia and RT n=10 Participants Combined hyperthermia and radiation therapy
Local Tumor Progression Free Survival Rate After Combined Hyperthermia and RT	18.5 Months Interval 15.1 to 21.9

SECONDARY outcome

Timeframe: Adverse event will be evaluated at 3 month. The common terminology criteria for adverse events (CTCAE) version 4.0 will be used.

All grade III or higher toxicities (repeated measure)

Outcome measures

Measure	Combined Hypertermia and RT n=10 Participants Combined hyperthermia and radiation therapy
Adverse Event After Combined Hyperthermia and RT.	1 participants

SECONDARY outcome

Timeframe: Pathient will be evaluated at 3 month after combined hyperthermia and RT.

Overall survival will be measured from the date of RT start to the date of death or last follow-up visit.

Outcome measures

Measure	Combined Hypertermia and RT n=10 Participants Combined hyperthermia and radiation therapy
Overall Survival Rate After Combined Hyperthermia and RT	18 Months Interval 15.1 to 19.0

Adverse Events

Combined Hypertermia and RT

Serious events: 4 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Combined Hypertermia and RT n=11 participants at risk Combined hyperthermia and radiation therapy
Respiratory, thoracic and mediastinal disorders Death	36.4% 4/11 • Number of events 5

Other adverse events

Adverse event data not reported

Additional Information

Professor

Samsung Medical Center

Phone: 82-2-3410-2612

Email: hee.ro.park@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place