Effectiveness and Safety of the Simultaneous Radiotherapy and Hyperthermia After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients Combined With Portal Vein Tumor Thrombosis

NCT01911000 | Completed Phase 2

• 1 other identifier: 2013-06-013-003
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of portal vein tumor thrombosis (PVTT)in patients with 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, 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 option in those patients. Investigators previously reported the retrospective study that the scheduled interval TACE followed by RT for HCC combined with PVTT and 60% of the patients showed objective response without significant elevation of complication. It is reported that hyperthermia considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to evaluate the objective response and adverse event in the combination treatment of RT and hyperthermia after Transarterial chemoembolization (TACE) in the unresectable HCC patients who combined with PVTT.

Conditions

Carcinoma. Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Hyperthermia effect and averse event in RT for HCC with PVTT

  Modified response evaluation criteria in solid tumor(mRECIST) will be used. Objective response was defined as complete and partial response. The common terminology criteria for adverse events (CTCAE version 4.0) will be used to evaluate the adverse events.

  Radiologic response and adverse event will be evaluated at 3 month after treatment.

Secondary Outcomes (6)

• Hyperthermia effect on local progression free survival rate

  The liver CT or MRI will be examined at 3 month after treatment and used to determine the response and presence of progression.

• To measure the time to local tumor progression

  The liver CT or MRI will be examined at 3 month after treatment.

• To measure the overall survival

  First follow up will be at 1 month after treatment.

• Quality of life (QoL) change before and after treatment

  QoL will be assessed before, 1, 3, 6 months after RT and compared each other.

• To validate of the prognostic index of portal vein tumor thrombosis in HCC (PITH) staging system

  The liver CT or MRI will be examined at 3 month after treatment

Study Arms (1)

RTHT

EXPERIMENTAL

RT and hyperthermia after TACE in the unresectable HCC patients who combined with PVTT

Radiation: RT and hyperthermia after TACE

Interventions

RT and hyperthermia after TACE RADIATION

RTHT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI
• Eastern cooperative oncology group performance status 0 1 2
• Age ≥ 20
• Unsuitable for resection or transplant or RFA
• Unsuitable for or refractory to TACE or drug eluting beads (DEB)
• Agreement of study-specific informed consent
• Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
• Child-Pugh score A-B within 7 days prior to study entry
• Normal liver (Liver minus gross tumor volume) ≥ 700 cc
• 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
• Male, consent contraception at least 6 months

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Hee Chul Park, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 30, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-05

Locations

KR (1)