HyperthermiaNCT01963117
Effectiveness of the Combined WLI and Hyperthermia for GI Cancer Liver Metastasis
A study testing Combined hyperthermia and radiation therapy in people with Hyperthermia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is chemotherapy, but considerable portion of the patients progressed and most of the liver is converted to metastatic tumor lesions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Combined hyperthermia and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Patients must have a diagnosis of pathologic proven gastrointestinal tract cancer
- 2 Unresectable and unsuitable to other local modalities
- 3 Not responded and/or unsuitable to chemotherapy
- 4 Eastern Cooperative Oncology Group ECOG) performance status 0 to 3
- 5 Assessment by colorectal tumor board (surgeon, radiation oncologist and medical oncologist participated)
- 6 Age ≥ 20
Show all 14Show fewer
- 7 Agreement of study-specific informed consent
- 8 Blood work requirements
- Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 50,000/mm3, Hgb ≥ 8 g/dl
- Liver function test(LFT): Total bilirubin<3.0 mg/dL, International normalized ratio(INR) < 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)< 6 X normal
- Serum creatinine < 1.5 X normal, or Creatinine clearance rate (CCr) ≥ 60 mL/min
- 9 Child-Pugh score 10 or less within 1 week before WLI
- 10 Childbearing potential woman, consent contraception at least 6 months
- 11 Stable breathing more than 5 minutes
Who cannot join
- 1 Life expectancy less than 8 weeks
- 2 Pregnant and/or breastfeeding woman
- 3 Previous upper abdominal RT history
- 4 Uncontrolled ascites or hepatic encephalopathy
- 5 Unstable respiration due to pleural effusion, chronic obstructive pulmonary disease COPD) etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Combined Whole Liver Irradiation (WLI) and Hyperthermia for Unresectable Chemoresistant Multiple Liver Metastasis From Gastrointestinal Tract Cancer: Prospective Phase II Trial
The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is chemotherapy, but considerable portion of the patients progressed and most of the liver is converted to metastatic tumor lesions. Significant quality of life decrement was detected in those patients, especially in patients suffered severe symptoms Several studies reported that whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable liver metastasis in gastrointestinal tract cancer patients. However, it is well known fact that the liver is a very sensitive to RT. Despite symptom palliation is obtained after 20 to 30 Gy RT but only in small subset of patients get local control. In this aspect, the combined with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and control local tumor progression, and increase the quality of life ultimately.
It is reported that hyperthermia is considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to investigate the effect of combination treatment of WLRT and hyperthermia on quality of life in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract cancer.
Read the detailed description
1.1 gastrointestinal tract cancer liver metastasis Most mortality of the gastrointestinal tract cancer patients is related with distant metastasis, especially liver is the main site. It has been estimated that 25% of colorectal cancer patients have hepatic metastases at diagnosis, and another 50% will have their tumor recurrence in the liver within 5 years.
Selected patients who had oligo (usually 2 to 3) or isolated liver metastases resected curatively and have yielded 5-year survival rates of 50% to 60%, showing that local therapy has the potential to cure. It is only possible in less than 25% of all patients with hepatic metastasis because of medical and/or surgical reasons, furthermore two-thirds of resected patients showed ultimately liver recurrence within 2 years.
The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is chemotherapy, but considerable portion of the patients progressed and most of the liver is converted to metastatic tumor lesions. Significant quality of life decrement was detected in those patients, especially in patients suffered severe symptoms
1.2 Radiation therapy (RT) for liver metastasis Several studies reported that whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable liver metastasis in colorectal cancer patients. However, it is well known fact that the liver is a very sensitive to RT. The radiation induced liver disease (RILD), dreadful complication without special treatment method and subset of patients could be dead, can be developed as low as 30 gray (Gy). Despite symptom palliation is obtained after 20 to 30 Gy RT but only in small subset of patients get local control. In this aspect, the combined with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and control local tumor progression, and increase the quality of life ultimately.
1.3 Hyperthermia It is reported that hyperthermia is effective in S phase, Low oxygen partial pressure (pO2), low hydrogen ion concentration (pH), and low perfusion site which are known as radio-resistant. Because of these characteristics, it considered as the most valuable radiosensitizer in cancer treatment, theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor reoxygenation.
1.4 Purpose of this study Based on those studies, we start this prospective study to investigate the effect of combination treatment of WLRT and hyperthermia on quality of life in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract cancer.
- Conditions
- Hyperthermia
- Being tested
- Combined hyperthermia and radiation therapy
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined hyperthermia and radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Combined hypertermia and RT | Experimental | Combined hypertermia and radiothearpy Receives: Radiation: Combined hyperthermia and radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Local Tumor Progression After Combined Hyperthermia and RT
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.
Measured: 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.
Secondary outcomes (5)
Objective Response Rate of Combined Hyperthermia and RT
Measured: Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.
Change in the Grade of Quality of Life at 3 Months From That Before the Combined Hyperthermia and RT
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)
Measured: 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.
Local Tumor Progression Free Survival Rate After Combined Hyperthermia and RT
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.
Measured: Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.
Adverse Event After Combined Hyperthermia and RT.
All grade III or higher toxicities (repeated measure)
Measured: Adverse event will be evaluated at 3 month. The common terminology criteria for adverse events (CTCAE) version 4.0 will be used.
Overall Survival Rate 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.
Measured: Pathient will be evaluated at 3 month after combined hyperthermia and RT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionApr 2015
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Chul Park, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963117
- Sponsor's protocol ID
- SMC IRB 2013-06-040
- Status last verified
- Aug 2014
- First submitted
- 25 Sep 2013
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Combined Whole Liver Irradiation (WLI) and Hyperthermia for Unresectable Chemoresistant Multiple Liver Metastasis From Gastrointestinal Tract Cancer: Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT01963117
- Acronym / sponsor ID
- SMC IRB 2013-06-040
- Conditions
- Hyperthermia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is chemotherapy, but considerable portion of the patients progressed and most of the liver is converted to metastatic tumor lesions. Significant quality of life decrement was detected in those patients, especially in patients suffered severe symptoms Several studies reported that whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable liver metastasis in gastrointestinal tract cancer patients. However, it is well known fact that the liver is a very sensitive to RT. Despite symptom palliation is obtained after 20 to 30 Gy RT but only in small subset of patients get local control. In this aspect, the combined with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and control local tumor progression, and increase the quality of life ultimately.
It is reported that hyperthermia is considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to investigate the effect of combination treatment of WLRT and hyperthermia on quality of life in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract cancer.
Detailed description
1.1 gastrointestinal tract cancer liver metastasis Most mortality of the gastrointestinal tract cancer patients is related with distant metastasis, especially liver is the main site. It has been estimated that 25% of colorectal cancer patients have hepatic metastases at diagnosis, and another 50% will have their tumor recurrence in the liver within 5 years.
Selected patients who had oligo (usually 2 to 3) or isolated liver metastases resected curatively and have yielded 5-year survival rates of 50% to 60%, showing that local therapy has the potential to cure. It is only possible in less than 25% of all patients with hepatic metastasis because of medical and/or surgical reasons, furthermore two-thirds of resected patients showed ultimately liver recurrence within 2 years.
The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is chemotherapy, but considerable portion of the patients progressed and most of the liver is converted to metastatic tumor lesions. Significant quality of life decrement was detected in those patients, especially in patients suffered severe symptoms
1.2 Radiation therapy (RT) for liver metastasis Several studies reported that whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable liver metastasis in colorectal cancer patients. However, it is well known fact that the liver is a very sensitive to RT. The radiation induced liver disease (RILD), dreadful complication without special treatment method and subset of patients could be dead, can be developed as low as 30 gray (Gy). Despite symptom palliation is obtained after 20 to 30 Gy RT but only in small subset of patients get local control. In this aspect, the combined with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and control local tumor progression, and increase the quality of life ultimately.
1.3 Hyperthermia It is reported that hyperthermia is effective in S phase, Low oxygen partial pressure (pO2), low hydrogen ion concentration (pH), and low perfusion site which are known as radio-resistant. Because of these characteristics, it considered as the most valuable radiosensitizer in cancer treatment, theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor reoxygenation.
1.4 Purpose of this study Based on those studies, we start this prospective study to investigate the effect of combination treatment of WLRT and hyperthermia on quality of life in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined hypertermia and RT | Experimental | Radiation: Combined hyperthermia and radiation therapyCombined hypertermia and radiothearpy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1 Patients must have a diagnosis of pathologic proven gastrointestinal tract cancer
- 2 Unresectable and unsuitable to other local modalities
- 3 Not responded and/or unsuitable to chemotherapy
- 4 Eastern Cooperative Oncology Group ECOG) performance status 0 to 3
- 5 Assessment by colorectal tumor board (surgeon, radiation oncologist and medical oncologist participated)
Key exclusion criteria (5 listed)
- 1 Life expectancy less than 8 weeks
- 2 Pregnant and/or breastfeeding woman
- 3 Previous upper abdominal RT history
- 4 Uncontrolled ascites or hepatic encephalopathy
- 5 Unstable respiration due to pleural effusion, chronic obstructive pulmonary disease COPD) etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined hyperthermia and radiation therapy | Radiation | Combined hypertermia and RT |
Primary outcome
Time to Local Tumor Progression After Combined Hyperthermia and RT
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.
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.
5 secondary outcomes
Objective Response Rate of Combined Hyperthermia and RT
Time frame: Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.
Change in the Grade of Quality of Life at 3 Months From That Before the Combined Hyperthermia and RT
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.
Local Tumor Progression Free Survival Rate After Combined Hyperthermia and RT
Time frame: Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.
Adverse Event After Combined Hyperthermia and RT.
Time frame: Adverse event will be evaluated at 3 month. The common terminology criteria for adverse events (CTCAE) version 4.0 will be used.
Overall Survival Rate After Combined Hyperthermia and RT
Time frame: Pathient will be evaluated at 3 month after combined hyperthermia and RT.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Chul Park, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined hyperthermia and radiation therapy in people with Hyperthermia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Local Tumor Progression After Combined Hyperthermia and RT (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.