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

NCT ID: NCT01963117

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Hyperthermia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined hypertermia and RT

Combined hypertermia and radiothearpy

Group Type: EXPERIMENTAL

Combined hyperthermia and radiation therapy

Intervention Type: RADIATION

Interventions

Combined hyperthermia and radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hee Chul Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SMC IRB 2013-06-040

Identifier Type: -

Identifier Source: org_study_id