drugset / Trial / NCT00510627
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-08
- Primary completion
- —
- Completion
- 2010-12
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Background Yoon SS, Tanabe KK. Surgical treatment and other regional treatments for colorectal cancer liver metastases. Oncologist. 1999;4(3):197-208.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Irinotecan | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |