Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date † | September 20, 2005 | ||||||||
Last Updated Date | May 1, 2009 | ||||||||
Start Date † | August 2005 | ||||||||
Current Primary Outcome Measures † |
Disease-free survival at 3 years [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00217737 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
|
||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer | ||||||||
Official Title † | A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers | ||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any remaining tumor cells or prevent the cancer from coming back. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone or observation only in treating colon cancer. PURPOSE: This randomized phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer. |
||||||||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (IIA vs IIB) and microsatellite stability (MSS) (stable vs low-grade instability [MSI-L]). Patients with disease that is at high risk for microsatellite instability (MSI) and loss of heterozygosity (LOH) at chromosome 18q are randomized to 1 of 2 treatment arms (arms I and II). Patients with disease that is at low risk for MSI and 18q LOH are assigned to arm III.
PROJECTED ACCRUAL: A total of 3,610 patients will be accrued for this study within 5.8 years. |
||||||||
Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Active Control | ||||||||
Condition † | Colorectal Cancer | ||||||||
Intervention † |
|
||||||||
Study Arms / Comparison Groups |
|
||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status † | Suspended | ||||||||
Estimated Enrollment † | 3610 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | 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
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States, Canada, Peru, Puerto Rico, South Africa | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00217737 | ||||||||
Responsible Party | Robert L. Comis, ECOG Group Chair's Office | ||||||||
Secondary IDs †† | ECOG-E5202 | ||||||||
Study Sponsor † | Eastern Cooperative Oncology Group | ||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||
Investigators † |
|
||||||||
Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | April 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |