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

NCT ID: NCT02290977

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Portal Vein Tumor Thrombosis

Keywords

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RT, TACE

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Scheduled TACE-RT

RT will be delivered at two weeks after TACE for HCC combined PVTT.

Group Type EXPERIMENTAL

Scheduled interval TACE - RT

Intervention Type RADIATION

RT will be administered at 2 weeks after TACE in HCC combined PVTT

Interventions

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Scheduled interval TACE - RT

RT will be administered at 2 weeks after TACE in HCC combined PVTT

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Paik Yong Han

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Han Paik, Professor

Role: CONTACT

Phone: 82-2-3410-2612

Email: [email protected]

Ju Yeon Cho, MD

Role: CONTACT

Phone: 82-2-3410-2612

Email: [email protected]

Facility Contacts

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Yong Han Paik, MD, PhD

Role: primary

Other Identifiers

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2014-07-009

Identifier Type: -

Identifier Source: org_study_id