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
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Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | November 6, 2000 | |||||||||||||||
First Posted Date ICMJE | January 27, 2003 | |||||||||||||||
Last Update Posted Date | April 18, 2011 | |||||||||||||||
Study Start Date ICMJE | September 2000 | |||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||
Current Primary Outcome Measures ICMJE | Not Provided | |||||||||||||||
Original Primary Outcome Measures ICMJE | Not Provided | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer | |||||||||||||||
Official Title ICMJE | Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study | |||||||||||||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES:
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.
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.
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. |
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||
Study Design ICMJE | Primary Purpose: Treatment | |||||||||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||||||||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Unknown status | |||||||||||||||
Enrollment ICMJE | Not Provided | |||||||||||||||
Original Enrollment ICMJE | Not Provided | |||||||||||||||
Study Completion Date ICMJE | Not Provided | |||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Norway, Portugal, Sweden, United Kingdom | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00006479 | |||||||||||||||
Other Study ID Numbers ICMJE | CDR0000068309 EORTC-40983 AGITG-EORTC-40983 ALM-CAO-EORTC-40983 CRUK-LON-EORTC-40983 FFCD-EORTC-40983 EU-20048 CRC-EORTC-40983 |
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Has Data Monitoring Committee | Not Provided | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Current Responsible Party | Not Provided | |||||||||||||||
Original Responsible Party | Same as current | |||||||||||||||
Current Study Sponsor ICMJE | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||||||||
Original Study Sponsor ICMJE | EORTC Gastrointestinal Tract Cancer Cooperative Group | |||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||||||||||||||
Verification Date | December 2000 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |