Carcinoma, HepatocellularPhase 2NCT01669668
Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)
A Phase 2 study testing radiofrequency ablation and laparoscopy in people with Carcinoma, Hepatocellular, run by Washington University School of Medicine.
Trial summary
This phase II trial studies how effectively radiofrequency ablation prevents recurrence of hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- radiofrequency ablation and laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven HCC or unambiguous radiologic findings consistent with HCC (> 1 cm tumor with arterial hypervascularity and venous or delayed phase washout) in patients with underlying liver disease.
- Disease must be considered unresectable (as defined by protocol).
- Age between 18 and 69 (inclusive).
- Karnofsky performance status of ≥ 80%
- Normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
Show all 16Show fewer
- absolute neutrophil count ≥1,500/mcL
- platelets >100,000/mcL
- total bilirubin <2.0 mg/dL
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Presence of ≤ 3 tumors, all of which are ≤ 3 cm in size. This will be determined preoperatively and confirmed by intraoperative ultrasound.
- Liver function of Child-Pugh class A or B
- Tumor(s) must be more than 2 cm away from of major biliary duct or major blood vessel defined as the main portal vein and its right and left primary branches and the first 1 cm of the secondary branches of the common hepatic duct and its right and left primary branches or the first 1 cm of its secondary branches.
- Able to understand and willing to sign a written informed consent document.
Who cannot join
- Hepatic tumor(s) with satellite lesions. A satellite lesion is defined as a tumor which is within 2 cm of the tumor being assessed for treatment and which has a diameter of less than 33% of the diameter of the tumor being assessed for treatment.
- Evidence of metastatic/extrahepatic disease based on abdominal and chest CT performed within 4 weeks of the procedure.
- Extrahepatic disease upon laparoscopy performed at the time of RFA. If extrahepatic disease is discovered at this laparoscopy, RFA will not be performed, and the patient will be considered ineligible for this study and will be replaced.
- Pregnancy. All women of childbearing potential must have a negative pregnancy test prior to enrollment in the study.
- Significant portal hypertension based on evidence of esophageal varices or ascites. Minimal portal hypertension or ascites will not be an exclusion criterion.
- Previous history of HCC or any other non-cutaneous malignancy.
- Patients who are found to be ineligible due to intraoperative findings will be recorded as to the cause of ineligibility. They will not be counted as accrued patients.
- -Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.
About this study
Official title: Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma
This phase II trial studies how effectively radiofrequency ablation prevents recurrence of hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- radiofrequency ablation, laparoscopy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
Undergo RFA
laparoscopyProcedure or surgery
Undergo laparoscopic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| RFA | Experimental | Patients undergo laparoscopic ultrasound followed by RFA. Receives: Procedure: radiofrequency ablation; Procedure: laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence, defined as the recurrence at the size of original tumor
Local recurrence will be summarized using descriptive statistics.
Measured: Up to 2 years
Secondary outcomes (4)
Morbidity and mortality associated with RFA under ideal conditions
The incidences of surgical complications and procedure-related death will be calculated.
Measured: 30 days
Overall survival rate
Kaplan-Meier product limit method will be used to estimate the 2-year overall survival. The median overall survival will also be
Measured: At 2 years
Disease-free survival rate
Kaplan-Meier product limit method will be used to estimate the 2-year disease-free survival. The median disease-free survival will also be estimated.
Measured: At 2 years
Ability of patients who develop recurrence to undergo salvage transplantation
At the time of recurrence, the patient is evaluated to see if she/he falls within the Milan criteria; if she/he does, then she/he is considered able to undergo salvage transplantation.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startDec 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Lack of referrals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Strasberg, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669668
- Sponsor's protocol ID
- 201207113
- Status last verified
- Jul 2014
- First submitted
- 16 Aug 2012
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01669668
- Acronym / sponsor ID
- 201207113
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of referrals.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how effectively radiofrequency ablation prevents recurrence of hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA | Experimental | Procedure: radiofrequency ablation, Procedure: laparoscopyPatients undergo laparoscopic ultrasound followed by RFA. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven HCC or unambiguous radiologic findings consistent with HCC (> 1 cm tumor with arterial hypervascularity and venous or delayed phase washout) in patients with underlying liver disease.
- Disease must be considered unresectable (as defined by protocol).
- Age between 18 and 69 (inclusive).
- Karnofsky performance status of ≥ 80%
- Normal organ and marrow function as defined below:
Key exclusion criteria (8 listed)
- Hepatic tumor(s) with satellite lesions. A satellite lesion is defined as a tumor which is within 2 cm of the tumor being assessed for treatment and which has a diameter of less than 33% of the diameter of the tumor being assessed for treatment.
- Evidence of metastatic/extrahepatic disease based on abdominal and chest CT performed within 4 weeks of the procedure.
- Extrahepatic disease upon laparoscopy performed at the time of RFA. If extrahepatic disease is discovered at this laparoscopy, RFA will not be performed, and the patient will be considered ineligible for this study and will be replaced.
- Pregnancy. All women of childbearing potential must have a negative pregnancy test prior to enrollment in the study.
- Significant portal hypertension based on evidence of esophageal varices or ascites. Minimal portal hypertension or ascites will not be an exclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablationUndergo RFA | Procedure or surgery | RFA |
| laparoscopyUndergo laparoscopic ultrasound | Procedure or surgery | RFA |
Primary outcome
Local recurrence, defined as the recurrence at the size of original tumor
Time frame: Up to 2 years
Local recurrence will be summarized using descriptive statistics.
4 secondary outcomes
Morbidity and mortality associated with RFA under ideal conditions
Time frame: 30 days
Overall survival rate
Time frame: At 2 years
Disease-free survival rate
Time frame: At 2 years
Ability of patients who develop recurrence to undergo salvage transplantation
Time frame: Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Related trials for Carcinoma, Hepatocellular
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Strasberg, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiofrequency ablation and laparoscopy in people with Carcinoma, Hepatocellular, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence, defined as the recurrence at the size of original tumor (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.