Transcript ACRIN 6673

ACRIN 6673
Percutaneous Radiofrequency Ablation
of Hepatocellular Carcinoma
in Cirrhotic Patients:
A Multi-Center Study
Protocol Team
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Gerald D. Dodd, M.D. – P.I.
Jeffrey Blume, Ph.D. – Statistician
Damian Dupuy, M.D. – Radiologist
David Lu, M.D. – Radiologist
Glenn Halff, M.D. – Surg. Oncologist
Shahla Masood, M.D. – Pathologist
Anthony Shields, M.D. – Med. Oncologist
Abstract
• Primary Objective:
To estimate proportion of patients
undergoing solitary or repetitive RFA
treatment sessions in whom all hepatic
tumors can be controlled with no
identifiable intrahepatic tumor present by
CT scan at 18 months following initiation
of therapy
Abstract
• Important Aspect:
Repeat RFA will be allowed
throughout the study (for 15 months
after initial treatment) in an attempt
to control all hepatic tumors.
Abstract
• Potential Candidates:
Adult patients with cirrhosis and
HCC in whom surgical resection is
contraindicated
Abstract
• Procedure:
All participants will undergo baseline
chest and abdomen CT scans.
Abstract
• Patient Population Heterogeneity
Controlled by:
– limiting enrollment to participants with
minimal intrahepatic hepatic tumor
burden and no evidence of extrahepatic tumor
– categorizing participants based on
severity of hepatic dysfunction
Abstract
• Tumor Burden Must Comply With
Milan Criteria:
–3 or fewer tumors ≤ 3.0 cm, or
–a single tumor > 3.0 cm but ≤ 5 cm
in diameter
Abstract
• Hepatic Dysfunction Defined
Using MELD Score
• Participants Enrolled Into One of
Three Groups:
–MELD Score >25
–MELD Score 15-25
–MELD Score <15
Abstract
• Study Type: Feasibility
• Enrollment in Each Cohort: 40
–Each cohort will be closed as target
enrollment is achieved.
• Total Study Enrollment: 120
Abstract
• Participants Follow up:
– Participants followed for 18 months by
serial CT scan after the initial ablation
session.
– Evidence of residual or recurrent tumor
at treated site on or after first 3-month
follow-up CT scan classified as a
primary failure
Abstract
– Continued control of all hepatic tumors
(baseline, recurrent, and new) may
impact survival.
– All intrahepatic tumor discovered
throughout the study will be ablated as
feasible and clinically indicated for 15
months after initiation of ablation
therapy.
Objectives
• Primary Objective:
To estimate the proportion of participants
undergoing solitary or repetitive RFA
treatment sessions whose livers have no
identifiable tumor by CT scan at 18
months following initiation of ablative
therapy.
Objectives
• Secondary Objectives:
– Explore impact of solitary versus
repetitive RFA on the main objective.
– Evaluate possible correlation between
MELD Score and the main objective.
– Estimate local and remote intrahepatic,
as well as the extra-hepatic, tumor
recurrence rates and their impact on the
main objective.
Objectives
–Explore impact of tumor size on
local tumor control rates.
–Explore impact of solitary or
repetitive RFA with or without
local/regional control on the
development of extra-hepatic
tumor.
Eligibility
• 18 years and older
• Biopsy proven cirrhosis, or typical findings of
cirrhosis by CT scan
• One of the following:
–Biopsy-proven hepatocellular carcinoma (HCC)
–Discrete hepatic tumor(s) as defined by
Barcelona criteria: 2 imaging studies showing
hypervascular tumor > 2cm or single imaging
study showing hypervascular tumor > 2cm with
AFP ≥ 400 ng/mL
–Discrete hypervascular tumor present on two
consecutive imaging studies (CT or MRI) with
documented growth of > 1cm in diameter
Eligibility
• Hepatic tumor burden meeting Milan
Criteria: 3 or fewer tumors ≤ 3.0 cm, or a
single tumor > 3.0 cm but ≤ 5 cm in
diameter
• All identified tumors deemed treatable by
percutaneous RFA by site PI
• All tumors ≥ 1 cm from main, right, and left
portal veins
• All tumors ≥ 1 cm from hollow viscera
• Performance status 0-2 on Zubrod
Performance Scale
Eligibility
• Serum creatinine < 2.0 mg/dl
• Study-specific signed informed consent
• Not a candidate for surgical resection
• No previous or current treatment for HCC
by any method (radiation therapy,
chemotherapy, chemoembolization, cryoablation); agrees not to be treated by these
therapies while on study.
Ablation Equipment
• Requirements:
–Valley Lab ablation equipment
chosen because it is most
commonly used by radiologists
–Limited to one manufacturer’s
device to minimize potential impact
of different devices.
Ablation Experience
• Participating Physician:
–must have treated at least 5 of those
patients using Valley Lab
equipment
–must have ablated hepatic tumors in
at least 15 patients
Imaging
• Procedures:
–3-phase CT scans of the abdomen
are the only imaging technique for
assessing eligibility and for followup.
–Pre-enrollment CT scans of chest
and abdomen must be performed
within 60 days prior to initial RFA.
Imaging
–Follow-up 3-phase CT scans of
abdomen must be performed within
one week following ablation and
every 3 months for 18 months.
–If repeat ablation is performed for
recurrent tumor, new baseline CT
scan must be performed within one
week.
Pathology
• Requirements:
–If patient undergoes resection,
transplantation, or autopsy,
pathological results of the status of
tumor in the liver will be recorded.
»Those results will not be included in
assessment of primary objective.
Enrollment
• Goals:
–Participant accrual will be
completed within 1.5 years of
activation.
–Protocol team hopes enrollment can
be completed in 1 year.
Thanks
The protocol team appreciates
the efforts of the individuals
and sites working on this
protocol.