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

Stanford University

Status and phase: Terminated; Phase 3

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

Treatments: Drug: embolic agent; Procedure: Transarterial Chemoembolization; Drug: lipiodol; Radiation: Stereotactic Body Radiation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02762266

P30CA124435 (U.S. NIH Grant/Contract)

NCI-2016-00418 (Registry Identifier)

IRB-35937

HEP0052 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Arm I (TACE)

Active Comparator group

Description:

Patients undergo TACE.

Treatment:

Drug: lipiodol

Procedure: Transarterial Chemoembolization

Drug: embolic agent

Arm II (SBRT)

Experimental group

Description:

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.

Treatment:

Radiation: Stereotactic Body Radiation Therapy