Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00066274|
Recruitment Status : Unknown
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 7, 2003
Last Update Posted : January 13, 2009
|First Submitted Date ICMJE||August 6, 2003|
|First Posted Date ICMJE||August 7, 2003|
|Last Update Posted Date||January 13, 2009|
|Study Start Date ICMJE||May 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00066274 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer|
|Official Title ICMJE||Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months for 1 year.
Patients are followed at 2 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Colorectal Cancer|
|Study Arms||Not Provided|
|Publications *||Bécouarn Y, Senesse P, Thézenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. Epub 2007 Sep 4.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years to 75 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||France|
|Removed Location Countries|
|NCT Number ICMJE||NCT00066274|
|Other Study ID Numbers ICMJE||CDR0000315384
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||UNICANCER|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||May 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP