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Transarterial Chemoembolization (TACE) With Radiation Therapy (RT) in Advanced Hepatocellular Carcinoma (HCC)

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ClinicalTrials.gov Identifier: NCT02290977
Recruitment Status : Unknown
Verified December 2014 by Paik Yong Han, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Paik Yong Han, Samsung Medical Center

Brief Summary:
The presence of portal vein tumor thrombosis (PVTT) in patients with hepatocellular carcinoma (HCC) is one of the most significant prognostic factors for poor prognosis, without treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT, Radiation therapy (RT) showed 50% of local control and about 10 months survival duration. Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an alternative option in those patients. Investigators previously reported the retrospective study that the scheduled interval Trans-catheter Arterial Chemo-embolization (TACE) followed by RT for HCC combined with PVTT and 60% of the patients showed objective response without significant elevation of complication. However, the prospective outcomes of TACE followed by RT for HCC are scantly reported. Based on those background, we start this prospective study to evaluate the clinical outcomes and adverse event in the RT after TACE in the unresectable HCC patients who combined with PVTT.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Portal Vein Tumor Thrombosis Radiation: Scheduled interval TACE - RT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scheduled Interval Trans-catheter Arterial Chemo-embolization and Radiation Therapy for Hepatocellular Carcinoma Combined With Portal Vein Tumor Thrombosis: Prospective Phase II Trial
Study Start Date : November 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Scheduled TACE-RT
RT will be delivered at two weeks after TACE for HCC combined PVTT.
Radiation: Scheduled interval TACE - RT
RT will be administered at 2 weeks after TACE in HCC combined PVTT




Primary Outcome Measures :
  1. Overall survival rate after scheduled TACE-RT for HCC with PVTT [ Time Frame: One year after treatment ]
    Overall survival rate will be evaluated at 1 year after treatment.

  2. Adverse event assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 after scheduled TACE-RT for HCC with PVTT [ Time Frame: Three months after treatment ]
    Adverse event will be evaluated at 3 months after treatment.


Secondary Outcome Measures :
  1. Radiologic response assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST) after scheduled TACE-RT for HCC with PVTT [ Time Frame: Three months after treatment ]
    Radiologic response will be evaluated at 3 months after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a diagnosis of HCC by at least one criterion listed below (korean liver cancer study group (KLCSG) guideline 2009) 1.1 Pathologically (histologically or cytologically) proven diagnosis of HCC 1.2 Liver nodule in high risk group 1.2.1 If alpha fetoprotein (AFP) ≥200 ng/mL , ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI 1.2.2 If AFP<200 ng/mL, ≥2 typical HCC enhancing pattern on dynamic contrast enhanced CT, MRI, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (LC), ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI
  2. Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI
  3. Eastern cooperative oncology group performance status 0 1 2
  4. Age ≥ 20 and 70 or less
  5. Unsuitable for resection or transplant or radiofrequency ablation (RFA)
  6. Unsuitable for or refractory to TACE or drug eluting beads (DEB)
  7. Agreement of study-specific informed consent
  8. Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
  9. Child-Pugh score A-B within 7 days prior to study entry
  10. Normal liver (Liver minus gross tumor volume) ≥ 700 cc
  11. Blood work requirements

    • Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 70,000/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 ≥ 60 mL/min
  12. Male, consent contraception at least 6 months
  13. Childbearing potential woman, consent contraception at least 6 months
  14. Life expectancy more than 12 weeks
  15. Stable breathing more than 5 minutes

Exclusion Criteria:

  • 1. Complete obstruction of main portal vein 2. Pregnant and/or breastfeeding woman 3. Previous upper abdominal RT history 4. Uncontrolled active co-morbidity 5. Another primary cancer history within 2 years 6. Uncontrolled ascites or hepatic encephalopathy 7. Connective tissue disease which known as radiation hypersensitivity 8. Uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290977


Contacts
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Contact: Yong Han Paik, Professor 82-2-3410-2612 yh.paik@samsung.com
Contact: Ju Yeon Cho, MD 82-2-3410-2612 juyeon.cho@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Yong Han Paik, MD, PhD       yh.paik@samsung.com   
Principal Investigator: Yong-Han Paik, MD, PhD         
Sub-Investigator: Hee Chul Park, MD, PhD         
Sub-Investigator: Ju-Yeon Cho, MD         
Sub-Investigator: Jeong Il Yu, MD         
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Paik Yong Han, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02290977    
Other Study ID Numbers: 2014-07-009
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Paik Yong Han, Samsung Medical Center:
RT, TACE
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Thrombosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases