Efficacy of Radiation Therapy and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma (HCC)

NCT01432314 | Withdrawn Phase 2 DMC

• 1 other identifier: HCLee3915
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators are to prospectively evaluate patient's survival, tumor response, and safety of RT followed by TACE in Child A patients with unilobar portal vein invasion.

Conditions

Hepatocellular Carcinoma

Keywords

patient's survival; tumor response; safety

Outcome Measures

Primary Outcomes (1)

• Time to tumor progression

  At the visiting time of D8, D15, D22, and D29, patients can visit at the outpatient clinic within the window period of ± 1 week. In addition, at the visiting time of D43, D71, D99, and W18, patients can visit at the outpatient clinic within the window period of ± 2 week. Progression of target region or appearance of new lesion will be checked at every visit.

  participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks

Secondary Outcomes (5)

• Progression-free survival of HCC patients

  participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks

• safety of RT followed by TACE

  participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks

• Overall survival of HCC patients

  participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks

• Time to TACE discontinuation

  participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks

• Best tumor response by modified RECIST (mRECIST) and RECIST criteria

  participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

Child A Hepatocellular carcinoma patients with unilobar portal vein invasion.

Other: Radiation therapy; Other: Transarterial chemoembolization

Interventions

Radiation therapy OTHER

A. Started 1 week after entry. B. Equipment: linear accelerator using 6-15 MV photons (external beam equipment). Computerized treatment planning system will be used to determine the radiation fields and 3D dose distribution. C. Target volume: include only the portal vein tumor thrombus and 2 cm margin into the contiguous HCC. Respiratory movement will be tracked (4D-CT). D. Dose: i) Dose for fraction: 3 Gy, at 5 fractions/week ii) Total dose: 45 Gy E. Criteria for stopping RT i) Development of grade 3 or 4 hepatotoxicity or gastrointestinal complications, as defined by CTCAE ver 4.0. Restart of RT should be within 2 weeks after stopping RT.

Also known as: RT

Treatment group

Transarterial chemoembolization OTHER

A. Start at 2 weeks after completion of RT. B. TACE procedure: cisplatin 2 mg/kg infusion with 5-20 mL of lipiodol emulsion through the target artery of HCC. Gelfoam embolization will be used until to no tumor staining on re-angiography. C. At an interval of 8 weeks twice, and then every 3 months until contraindications or complete response develop.

Also known as: TACE

Treatment group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and older than 18 years, and less than 70 years
• Histologically diagnosed HCC, or clinically diagnosed HCC based on the American Association of Study of Liver Disease (AASLD) noninvasive diagnostic criteria for HCC larger than 2 cm in diameter (Patients with chronic HBV or HCV infection, and/or evidence of liver cirrhosis, and typical enhancement pattern (arterial enhancement and portal or delayed washout) on dynamic computed tomography (CT) or magnetic resonance imaging (MRI), or mass with serum alpha fetoprotein level more than 200 ng/mL)
• Treatment naïve HCC patients or patients who received a locoregional therapy(-ies) (radiofrequency ablation, percutaneous ethanol injection, surgical resection; TACE is not allowed) to nontarget lesion at least 3 months prior to baseline scan
• HCC invasion to 1st or 2nd order branch of portal vein
• HCC greater than 2 cm and the tumor volume should be less than half of total liver volume
• CTP score 6 or less than 6 (Child A class only)
• ECOG performance status 0 or 1
• Women with childbearing potential and men must agree to use adequate contraception prior to study entry and during study participation
• Patients who refuse to use sorafenib
• The patient must give written, informed consent

You may not qualify if:

• Age of 70 and older, or younger than 18
• HCC less than 2 cm, or tumor volume larger than half of total liver volume
• Invasion to both right and left portal veins, or main portal vein
• Invasion to hepatic vein or inferior vena cava
• Presence of extrahepatic metastasis
• Recurred HCC after liver transplantation
• Prior history of any treatment to target lesion
• Any history of previous RT, TACE, sorafenib or other systemic therapy
• Prior locoregional therapy (radiofrequency ablation, percutaneous ethanol injection therapy, surgery) within 3 months before baseline scan
• CTP score more than 6 (Child class B or C)
• ECOG performance status more than 1
• Presence of ascites or encephalopathy
• Absolute neutrophil count less than 1,000/mm3
• Platelet count less than 60,000/mm3
• INR of prothrombin time more than 1.5

Sponsors & Collaborators

• Asan Medical Center: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiotherapy

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Han Chu Lee, M.D

  Department of Internal Medicine, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine

  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: PRINCIPAL INVESTIGATOR
• PI Title: Asan Medical Center

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 12, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06