Clinical trial · Interventional
Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms
NCT00019604CI-TRIAL-00025775terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal investigator left the institution.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 (FDG-PET) | Radiation | — | UNRESOLVED |
| gadopentetate dimeglumine | Radiation | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
| radionuclide imaging | Procedure | — | UNRESOLVED |
| ultrasound imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation in liver cancer
- description
- 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.
- interventionNames
- Procedure: computed tomography
- Procedure: magnetic resonance imaging
- Procedure: positron emission tomography
- Procedure: radiofrequency ablation
- Procedure: radionuclide imaging
- Procedure: ultrasound imaging
- Radiation: fludeoxyglucose F 18 (FDG-PET)
- Radiation: gadopentetate dimeglumine
Primary outcomes (1)
- measure
- Response
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.