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The Patients With Unresectable Chemoresistant Multiple Liver Metastasis From Colorectal Cancer | Effectiveness of the Combined Whole Liver Irradiation (WLI) and Hyperthermia for Gastrointestinal Tract Cancer Liver Metastasis

The Patients With Unresectable Chemoresistant Multiple Liver Metastasis From Colorectal Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

The Patients With Unresectable Chemoresistant Multiple Liver Metastasis From Colorectal Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:Combined hyperthermia and radiation therapy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Combined hypertermia and RT

Study Status

Terminated

Start Date: October 2013

Completed Date: April 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Time to local tumor progression after combined hyperthermia and RT

Secondary Outcome: Objective response rate of combined hyperthermia and RT

Study sponsors, principal investigator, and references

Principal Investigator: Hee Chul Park, M.D., Ph.D.

Lead Sponsor: Samsung Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01963117

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