Clinical trial · Interventional
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases
A Prospective, Randomized, Active-Control, Multi-Center Study Assessing Overall Survival Using Chemotherapy With or Without Impedance-Based Radiofrequency Ablation for Subjects With Colorectal Cancer and Incurable Metastatic Liver Disease, Failing at Least First-Line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Boston Scientific has decided to close the Study.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether patients treated with Radiofrequency Ablation (RFA) in conjunction with chemotherapy have a better overall survival rate than patients treated with chemotherapy alone.
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 Neoplasm | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Secondary Liver Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Radiofrequency Ablation (RFA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Radiofrequency ablation in conjunction with chemotherapy
- interventionNames
- Device: Radiofrequency Ablation (RFA)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Standard of care chemotherapy regimen
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- To evaluate Overall Survival in subjects receiving chemotherapy + RFA compared to chemotherapy alone.
- timeFrame
- Study duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All subjects must meet the following criteria: * Subject must have incurable metastatic colorectal cancer with metastatic disease to the liver * Subject must have extrahepatic metastatic disease, as confirmed by radiographic evidence or surgical/other documentation that cannot be treated by surgery or image guided therapy to an endpoint of no evidence of residual disease by imaging criteria * Subject has received and, in the opinion of the treating physician, progressed through at least one prior chemotherapy regimen for metastatic disease, or has developed recurrent disease on or within 6 months of completing adjuvant therapy * At least 50% of the total tumor burden is in the liver, as determined by the treating investigator, and prior to any study specified intervention (resection or ablation). * Subject must have no more than 10 hepatic tumors remaining after surgical resection, with no tumor exhibiting a unidimensional size greater than 5cm * Subject is medically eligible to receive RFA, as determined by the treating investigator * Subject is naïve to, and medically eligible (as defined by the treating investigator) to receive, at least one of the following: * an oxaliplatin containing regimen * an irinotecan containing regimen * an anti-EGFR monoclonal antibody-containing regimen (subject must be naïve to both cetuximab and panitumumab) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Age \> 18 years * Subject life expectancy \> 3 months * International Normalized Ratio (INR) \< 2.0 * Platelets \> 100 x103/mm3 * Total Bilirubin \<1.5mg/dl * Creatinine level \< 2.0 mg/dl * Must sign an Informed Consent form Exclusion Criteria: All subjects who meet any of the following criteria will not be enrolled into the study: * Subjects's extrahepatic disease is amenable to curative surgical or image guided therapy * Subject has known brain metastases * Uncorrectable coagulopathy * Subject is pregnant, nursing, or wishes to become pregnant during the study * Other serious medical condition(s) (e.g. uncontrolled infection, uncontrolled cardiac disease) that, in the opinion of the treating investigator, would preclude study treatment or impact survival. * Current or planned treatment with any experimental chemotherapy or biological agents
References
Publications (16)
- BACKGROUNDChapter 49, Colon, Rectal, and Anal Cancers. PART VI: THE CARE OF INDIVIDUALS WITH SPECIFIC CANCERS; pp: 1156-1214
- BACKGROUNDChoti MA, Bulkley GB. Management of hepatic metastases. Liver Transpl Surg. 1999 Jan;5(1):65-80. doi: 10.1002/lt.500050113. PMID 9873095
- BACKGROUNDCromheecke M, de Jong KP, Hoekstra HJ. Current treatment for colorectal cancer metastatic to the liver. Eur J Surg Oncol. 1999 Oct;25(5):451-63. doi: 10.1053/ejso.1999.0679. PMID 10527592
- BACKGROUNDKemeny NE, Atiq OT. Non-surgical treatment for liver metastases. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):593-610. doi: 10.1053/bega.1999.0050. PMID 10654922
- BACKGROUNDFong Y. Surgical therapy of hepatic colorectal metastasis. CA Cancer J Clin. 1999 Jul-Aug;49(4):231-55. doi: 10.3322/canjclin.49.4.231. PMID 11198884
- BACKGROUNDBowles BJ, Machi J, Limm WM, Severino R, Oishi AJ, Furumoto NL, Wong LL, Oishi RH. Safety and efficacy of radiofrequency thermal ablation in advanced liver tumors. Arch Surg. 2001 Aug;136(8):864-9. doi: 10.1001/archsurg.136.8.864. PMID 11485520
- BACKGROUNDBerber E, Pelley R, Siperstein AE. Predictors of survival after radiofrequency thermal ablation of colorectal cancer metastases to the liver: a prospective study. J Clin Oncol. 2005 Mar 1;23(7):1358-64. doi: 10.1200/JCO.2005.12.039. Epub 2005 Jan 31. PMID 15684312
- BACKGROUNDYoon SS, Tanabe KK. Surgical treatment and other regional treatments for colorectal cancer liver metastases. Oncologist. 1999;4(3):197-208. PMID 10394588
- BACKGROUNDDeMatteo RP, Fong Y, Blumgart LH. Surgical treatment of malignant liver tumours. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):557-74. doi: 10.1053/bega.1999.0048.