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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

Tracking Information
First Submitted Date  ICMJE September 25, 2013
First Posted Date  ICMJE October 16, 2013
Results First Submitted Date  ICMJE September 4, 2018
Results First Posted Date  ICMJE March 19, 2020
Last Update Posted Date March 19, 2020
Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2013)
Time to local tumor progression 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. ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2020)
  • 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. ]
    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)
  • 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. ]
    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.
  • 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. ]
    All grade III or higher toxicities (repeated measure)
  • Overall Survival Rate After Combined Hyperthermia and RT [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2013)
  • 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 from baseline quality of life at 3 months [ Time Frame: Quality of life will be evaluated at baseline, and 3 month after 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.
  • 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. ]
    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.
  • 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. ]
    Overall survival will be measured from the date of RT start to the date of death or last follow-up visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of the Combined WLI and Hyperthermia for GI Cancer Liver Metastasis
Official Title  ICMJE Effectiveness of the Combined Whole Liver Irradiation (WLI) and Hyperthermia for Unresectable Chemoresistant Multiple Liver Metastasis From Gastrointestinal Tract Cancer: Prospective Phase II Trial
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperthermia
Intervention  ICMJE Radiation: Combined hyperthermia and radiation therapy
Study Arms  ICMJE Experimental: Combined hypertermia and RT
Combined hypertermia and radiothearpy
Intervention: Radiation: Combined hyperthermia and radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 7, 2014)
11
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2013)
47
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01963117
Other Study ID Numbers  ICMJE SMC IRB 2013-06-040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hee Chul Park, M.D., Ph.D. Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP