Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases

NCT00510627 | Withdrawn Phase 4

• 1 other identifier: ONC-PM-032006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Metastatic Liver Cancer; Secondary Liver Cancer; Liver Neoplasm

Keywords

Metastatic Liver Cancer; Colorectal Cancer; Radiofrequency Ablation; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• To evaluate Overall Survival in subjects receiving chemotherapy + RFA compared to chemotherapy alone.

  Study duration

Secondary Outcomes (2)

• To evaluate any unanticipated adverse device effects.

  Two years

• To determine if there are differences in the incidence or severity of adverse events in the RFA + chemotherapy arm compared to the chemotherapy only arm.

  Study duration

Study Arms (2)

A

EXPERIMENTAL

Radiofrequency ablation in conjunction with chemotherapy

Device: Radiofrequency Ablation (RFA)

B

ACTIVE COMPARATOR

Standard of care chemotherapy regimen

Drug: Chemotherapy

Interventions

Radiofrequency Ablation (RFA) DEVICE

The RF3000 radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue.

Also known as: RF3000 Radiofrequency (RF) Generators, LeVeen Electrode, Co-Access Electrode, Soloist Electrode, SuperSlim Electrode

A

Chemotherapy DRUG

Standard of care chemotherapy regimen

Also known as: Oxaliplatin containing chemotherapy regimen, Irinotecan containing chemotherapy regimen, An anti-EGFR monoclonal antibody-containing regimen, Other

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

New York University

New York, New York, 10016, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (16)

• Chapter 49, Colon, Rectal, and Anal Cancers. PART VI: THE CARE OF INDIVIDUALS WITH SPECIFIC CANCERS; pp: 1156-1214

  BACKGROUND

• Choti MA, Bulkley GB. Management of hepatic metastases. Liver Transpl Surg. 1999 Jan;5(1):65-80. doi: 10.1002/lt.500050113.

  PMID: 9873095 BACKGROUND

• Cromheecke 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 BACKGROUND

• Kemeny 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 BACKGROUND

• Fong 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 BACKGROUND

• Bowles 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 BACKGROUND

• Berber 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 BACKGROUND

• Yoon SS, Tanabe KK. Surgical treatment and other regional treatments for colorectal cancer liver metastases. Oncologist. 1999;4(3):197-208.

  PMID: 10394588 BACKGROUND

• DeMatteo 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.

  PMID: 10654920 BACKGROUND

• Curley SA, Vecchio R. New trends in the surgical treatment of colorectal cancer liver metastases. Tumori. 1998 May-Jun;84(3):281-8. doi: 10.1177/030089169808400301.

  PMID: 9678609 BACKGROUND

• Dodd GD 3rd, Soulen MC, Kane RA, Livraghi T, Lees WR, Yamashita Y, Gillams AR, Karahan OI, Rhim H. Minimally invasive treatment of malignant hepatic tumors: at the threshold of a major breakthrough. Radiographics. 2000 Jan-Feb;20(1):9-27. doi: 10.1148/radiographics.20.1.g00ja019.

  PMID: 10682768 BACKGROUND

• Poston GJ. Radiofrequency ablation of colorectal liver metastases: where are we really going? J Clin Oncol. 2005 Mar 1;23(7):1342-4. doi: 10.1200/JCO.2005.10.911. Epub 2005 Jan 31. No abstract available.

  PMID: 15684315 BACKGROUND

• Pawlik TM, Abdalla EK, Ellis LM, Vauthey JN, Curley SA. Debunking dogma: surgery for four or more colorectal liver metastases is justified. J Gastrointest Surg. 2006 Feb;10(2):240-8. doi: 10.1016/j.gassur.2005.07.027.

  PMID: 16455457 BACKGROUND

• Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.

  PMID: 14657227 BACKGROUND

• Giantonio et. Al. High-dose bevacizumab in combination with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200

  BACKGROUND

• Talamonti MS, Tellez C, Benson AB 3rd. Local-regional therapy for metastatic liver tumors. Cancer Treat Res. 1998;98:172-99. No abstract available.

  PMID: 10326669 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms; Colorectal Neoplasms

Interventions

Radiofrequency Ablation; Radionuclide Generators; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Radiation Equipment and Supplies; Equipment and Supplies

Study Officials

• William Jacqmein

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 2, 2007
• Study Start: August 1, 2007
• Study Completion: December 1, 2010
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (2)