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
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | February 27, 2016 |
| End Date: | February 27, 2021 |
| Contact: | Samantha Wong |
| Email: | swong8@stanford.edu |
| Phone: | 650-498-8495 |
International Randomized Study of Transarterial Chemoembolization (TACE) Versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma After Initial TACE
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.
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.
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.
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.
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
- Life expectancy >= 6 months
- Albumin >= 2.4 g/dL
- Total bilirubin =< 3 mg/dL
- International normalized ratio (INR) =< 1.5
- Creatinine =< 2.0 mg/dL
- 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
We found this trial at
2
sites
Palo Alto, California 94304
Principal Investigator: Daniel T. Chang
Phone: 650-725-0438
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Sapporo, Hokkaido
Principal Investigator: Hiroki Shirato
Phone: 81-11-706-7600
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