|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 8, 2004 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | January 2001 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Recurrence rate and size of colorectal polyps reduction as measured by colonoscopy after 3-5 year of study treatment [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Recurrence rate and size of colorectal polyps reduction as measured by colonoscopy after 3-5 year of study treatment | ||||
| Change History | Complete list of historical versions of study NCT00078897 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Tolerance and adequate adherence to long term selenium treatment as measured by adverse events, serious adverse events, every 3-4 months during treatment, and laboratory values at the beginning of the study , 6 months and annually thereafter [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Tolerance and adequate adherence to long term selenium treatment as measured by adverse events, serious adverse events, and laboratory values every 3-4 months during treatment, and 1 month after study completion | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Selenium in Treating Patients With Adenomatous Colorectal Polyps | ||||
| Official Title ICMJE | Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence | ||||
| Brief Summary | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps. PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps. |
||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to use of low-dose (≤ 81 mg/day) aspirin (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients undergo follow-up colonoscopy approximately 5 years* after baseline colonoscopy. NOTE: Some patients will continue participation for up to 7 and a half years PROJECTED ACCRUAL: A total of 1,850 patients will be accrued for this study followed by a second accrual of 200 patients with advanced adenoma for a substudy. |
||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. Epub 2008 Mar 31. | ||||
|
* 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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 2050 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| 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
|
||||
| Gender | Both | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00078897 | ||||
| Responsible Party | M. Peter Lance, Arizona Cancer Center at University of Arizona Health Sciences Center | ||||
| Study ID Numbers ICMJE | CDR0000353185, UARIZ-00-0430-01, UARIZ-HSC-00142 | ||||
| Study Sponsor ICMJE | University of Arizona | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||