Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization

NCT ID: NCT02762266

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-27
• Study Completion Date: 2022-12-31

Brief Summary

This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer have been made (residual) or has come back (recurrent). TACE is a minimally invasive, image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may be able to send radiation directly to the tumor and cause less damage to normal liver tissue. It is not yet known whether TACE is more effective than SBRT or SABR in treating patients with persistent or recurrent liver cancer who have undergone initial TACE.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the freedom from local progression (FFLP) of TACE versus (vs) SABR in patients with persistent hepatocellular carcinoma (HCC) after TACE.

SECONDARY OBJECTIVES:

I. To determine the progression-free survival (PFS) of TACE vs SABR in patients with persistent HCC after initial TACE.

II. To determine the overall survival (OS) of TACE vs SABR for persistent HCC. III. To determine the toxicities associated with TACE or SABR for persistent HCC.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo TACE.

ARM II: Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks.

After completion of study treatment, patients are followed up for 1-2 weeks, 1, 3, 6, 12, and 18 months, and every 6 months up to 3 years.

Conditions

Child-Pugh Class A; Child-Pugh Class B; Recurrent Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (TACE)

Patients undergo TACE.

Group Type: ACTIVE_COMPARATOR

Transarterial Chemoembolization

Intervention Type: PROCEDURE

Undergo TACE

embolic agent

Intervention Type: DRUG

. Acceptable embolic agents include:

• Gelatin sponge (gelfoam)
• Polyvinyl alcohol (PVA) particles
• Microspheres / Embolic beads

lipiodol

Intervention Type: DRUG

Arm II (SBRT)

Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Undergo SBRT

Interventions

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type: RADIATION

Transarterial Chemoembolization

Undergo TACE

Intervention Type: PROCEDURE

embolic agent

. Acceptable embolic agents include:

• Gelatin sponge (gelfoam)
• Polyvinyl alcohol (PVA) particles
• Microspheres / Embolic beads

Intervention Type: DRUG

lipiodol

Intervention Type: DRUG

Other Intervention Names

SBRT; TACE

Eligibility Criteria

Inclusion Criteria

• Confirmed hepatocellular carcinoma (HCC) by one of the following:

• Histopathology
• One radiographic technique that confirms a lesion >= 1 cm with arterial hypervascularization with washout on delayed phase
• Radiographic evidence of persistent, progressive, or recurrent disease in an area previously treated with TACE and determined from 3 months after initial TACE; this evaluation should be within 6 weeks of date of study eligibility
• Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension; multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 10 cm as long as the dose constraints to normal tissue can be met
• Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2
• Patients with liver disease classified as Child Pugh class A or B, with score =< 9 ((within 4 weeks of treatment)
• Life expectancy >= 6 months
• Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document

Exclusion Criteria

• Prior radiotherapy to the upper abdomen
• Prior radioembolization to the liver
• Prior radiofrequency ablation (RFA) to index lesion
• Liver transplant
• Active gastrointestinal bleed within 2 weeks of study enrollment
• Ascites refractory to medical therapy (mild to moderate ascites is allowed)
• Women who are pregnant or breastfeeding
• Administration of chemotherapy within the last 1 month
• Extrahepatic metastases
• Participation in another concurrent treatment protocol
• Prior history of malignancy other than HCC, dermatologic basal cell or squamous cell carcinoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Erqi Liu Pollom

Associate Professor of Radiation Oncology (Radiation Therapy)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erqi Liu Pollom, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Daniel Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Countries

United States; Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2016-00418

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA124435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HEP0052

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-35937

Identifier Type: -

Identifier Source: org_study_id