Liver Cancer, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, liver metastases, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.
Detailed description
OBJECTIVES: * Evaluate the nature and duration of response of patients with primary or metastatic liver neoplasms, who are not candidates for surgical resection, treated with radiofrequency interstitial tissue ablation. * Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects of this therapy on tumor blood flow and tumor vascular density in these patients. * Determine the ability of positron emission tomography with fludeoxyglucose F 18 (FDG-PET) to monitor response after treatment with this therapy in these patients. * Compare FDG-PET results with computed tomography (CT) scan, biopsy, and serum marker results in patients treated with this therapy. * Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to assess the efficacy of this therapy in these patients. OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment. Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.
Interventions
PROCEDUREcomputed tomography
Scan to assess the effects of ablation.
PROCEDUREmagnetic resonance imaging
Imaging used to assess the effects of this ablative therapy on tumor vascular density.
PROCEDUREpositron emission tomography
Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.
PROCEDUREradiofrequency ablation
Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.
PROCEDUREradionuclide imaging
Imaging following injection of a radioactive material.
PROCEDUREultrasound imaging
An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.
RADIATIONfludeoxyglucose F 18 (FDG-PET)
FDG PET scans rely on metabolic changes to evaluate response to therapy.
RADIATIONgadopentetate dimeglumine
Food and Drug Administration approved contrast agent.
Sponsors
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed primary or metastatic liver lesions * Not a candidate for surgical resection * Must have six or fewer lesions and no single lesion greater than 7 cm in diameter * Extrahepatic disease allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 50,000/mm\^3 * Prothrombin time (PT) or partial thromboplastin time (PTT) no greater than 1.5 times control (except for therapeutically anticoagulated nonrelated medical conditions \[e.g., atrial fibrillation\]) Hepatic: * Bilirubin no greater than 3.0 mg/dL Renal: * Creatinine no greater than 2.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices * No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used in this study * Weight less than 136 kg PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior to radiofrequency ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response | — | Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Blood Flow | Baseline, 3 months, and 6 months following treatment | Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. |
| Tumor Vascular Density | Baseline, 3 months, and 6 months following treatment | Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density. |
| Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA) | Baseline, 6 weeks, 3 months, and 6 months following treatment | Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. |
| Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT) | Baseline, 6 weeks, 3 months, and 6 months following treatment | Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism). |
| Number of Participants With Adverse Events | 9 years, 9 months | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. |
| Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers | Baseline, 6 weeks, 3 months, and 6 months following treatment | Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points. |
| Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms | Baseline, 6 weeks, 3 months, and 6 months following treatment | Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., \<median change, \>median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point). |
| Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA) | Baseline, 6 weeks, 3 months, and 6 months following treatment | PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated. |
| Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies | Baseline, 6 weeks, 3 months, and 6 months following treatment | Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Ablation in Liver Cancer This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Carcinoid tumor, not treatable | 1 |
| Overall Study | Death | 1 |
| Overall Study | Details for other not available | 4 |
| Overall Study | Going to have liver transplant | 1 |
| Overall Study | Move to a different study | 1 |
| Overall Study | Non compliant | 1 |
| Overall Study | Non compliant on systemic CH | 1 |
| Overall Study | Progressive disease | 23 |
| Overall Study | Pt going to immunotherapy study | 1 |
| Overall Study | Refused treatment | 1 |
| Overall Study | Resectable disease | 1 |
| Overall Study | Started new chemo regimen | 1 |
| Overall Study | Too much disease | 1 |
| Overall Study | Unable to evaluate | 1 |
Baseline characteristics
| Characteristic | Radiofrequency Ablation in Liver Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 59.18 years STANDARD_DEVIATION 13.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gender Female | 21 Participants |
| Gender Male | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Response
Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.
Population: The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiofrequency Ablation in Liver Cancer | Response | Complete Response | 0 Participants |
| Radiofrequency Ablation in Liver Cancer | Response | Partial Response | 0 Participants |
| Radiofrequency Ablation in Liver Cancer | Response | Minor Response | 0 Participants |
| Radiofrequency Ablation in Liver Cancer | Response | Stable Disease | 0 Participants |
| Radiofrequency Ablation in Liver Cancer | Response | Progressive Disease | 23 Participants |
Secondary
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies
Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.
Time frame: Baseline, 6 weeks, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Secondary
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)
Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).
Time frame: Baseline, 6 weeks, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Secondary
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers
Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.
Time frame: Baseline, 6 weeks, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Secondary
Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms
Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., \<median change, \>median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).
Time frame: Baseline, 6 weeks, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Secondary
Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)
PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.
Time frame: Baseline, 6 weeks, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Secondary
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Time frame: 9 years, 9 months
Population: NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Ablation in Liver Cancer | Number of Participants With Adverse Events | NA Participants |
Secondary
Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)
Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.
Time frame: Baseline, 6 weeks, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Secondary
Tumor Blood Flow
Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.
Time frame: Baseline, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Secondary
Tumor Vascular Density
Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.
Time frame: Baseline, 3 months, and 6 months following treatment
Population: This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.