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

This study has been withdrawn prior to enrollment.
(Another phase 2 randomized study has been started by other investigators.)
Sponsor:
Information provided by (Responsible Party):
Han Chu Lee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01432314
First received: September 7, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Other: Radiation therapy
Other: Transarterial chemoembolization
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Radiation Therapy, Followed by Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma Invading 1st or 2nd Order Branch of Portal Vein

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Time to tumor progression [ Time Frame: participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Progression-free survival of HCC patients [ Time Frame: participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks ] [ Designated as safety issue: No ]
    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.

  • safety of RT followed by TACE [ Time Frame: participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks ] [ Designated as safety issue: Yes ]

    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.

    Safety evaluation will be performed according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.0).

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability


  • Overall survival of HCC patients [ Time Frame: participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks ] [ Designated as safety issue: No ]
    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.

  • Time to TACE discontinuation [ Time Frame: participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks ] [ Designated as safety issue: No ]
    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.

  • Best tumor response by modified RECIST (mRECIST) and RECIST criteria [ Time Frame: participants will be followed for the duration of hospital stay and outpatient visit, an expected average of 18 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Child A Hepatocellular carcinoma patients with unilobar portal vein invasion.
Other: Radiation therapy

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.

Other Name: RT
Other: Transarterial chemoembolization

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.

Other Name: TACE

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
  • Serum creatinine more than 1.5 mg/dL
  • AST or ALT more than 5x upper limit normal(ULN)(200 IU/L)
  • Bilirubin more than 3 mg/dL
  • Recent gastrointestinal bleeding including variceal bleeding within 3 months
  • History of active gastro-duodenal ulcers within the past 6 months. However, the patient is eligible if a more recent gastroscopy shows complete healing of ulcers.
  • Major surgery or serious non-healing wounds within 3 months of start of RT
  • Pregnancy or breastfeeding. All female patients with childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis and T1) (Any cancer curatively treated at least 3 years prior to entry is permitted).
  • Any active clinically serious infections (Grade 3, CTCAE version 4.0)
  • History of human immunodeficiency virus (HIV) infection
  • History of organ allograft
  • Patients who agree to use sorafenib
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432314

Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Han Chu Lee, M.D Department of Internal Medicine, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Han Chu Lee, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01432314     History of Changes
Other Study ID Numbers: HCLee3915
Study First Received: September 7, 2011
Last Updated: June 24, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
patient's survival
tumor response
safety

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2014