Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00006479|
Recruitment Status : Unknown
Verified December 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : April 18, 2011
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 3|
- Compare the progression-free and overall survival of patients with resectable colorectal liver metastases treated with surgery with or without neoadjuvant and adjuvant oxaliplatin, fluorouracil, and leucovorin calcium.
- Compare the percentage of patients with total resection with these two treatments.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, prior adjuvant chemotherapy (yes vs no), plasma CEA level in ng/mL at diagnosis of liver metastases (5 or less vs 6 to 30 vs 31 or greater), serosa extension of primary cancer (absent T1 or T2 vs present T3 or T4), lymphatic spread of primary cancer (absent vs present N+), time interval between diagnosis of primary tumor to metastases (2 years or more vs fewer than 2 years), and number of metastases (1 to 3 vs 4). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium (LV) IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2. Treatment repeats every 15 days for 6 courses in the absence of disease progression or unacceptable toxicity.
At 2 to 5 weeks after chemotherapy, patients undergo liver resection. Patients with progressive disease after 3 courses of chemotherapy undergo liver resection at least 2 weeks after completion of course 3 and do not receive postoperative chemotherapy.
At 2 to 5 weeks after surgery, patients receive oxaliplatin, LV, and 5-FU as in preoperative chemotherapy.
- Arm II: Patients undergo liver resection. Patients are followed every 3 months for 2 years and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study|
|Study Start Date :||September 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006479
|OverallOfficial:||Bernard Nordlinger, MD||Hopital Ambroise Pare|
|Study Chair:||Euan T. Walpole, MD||Princess Alexandra Hospital|
|Study Chair:||Wolf O. Bechstein, MD||Arbeitsgruppe Lebermetastasen und Tumoren|
|Study Chair:||John N. Primrose, MD||University Hospital Southampton NHS Foundation Trust|
|Study Chair:||Philippe Rougier, MD||Hopital Ambroise Pare|