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NCT01349881 · ClinicalTrials.gov registry record · Phase 3
S0820, Adenoma and Second Primary Prevention Trial
A Phase 3 study of Colorectal Neoplasms, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 3
- Development phase
- 354
- Enrollment target
- 20
- Study locations
NCT01349881: Active Phase 3 study of Colorectal Neoplasms, sponsored by SWOG Cancer Research Network.
NCT01349881 is a Phase 3 study of Colorectal Neoplasms that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 354 participants, below the 570-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349881, a Phase 3 study of Colorectal Neoplasms, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 354 participants
- Enrollment target
- 20
- Study locations
Study Summary
The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.
Primary Outcome
High risk adenoma is defined as either advanced adenoma (villous or tubulovillous histology, size \>= 1 cm, or high grade dysplasia) or multiple adenomas (3 or more each \> 0.3 cm). The primary analysis of the 3-year event rate will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A two-arm binomial design without continuity correction will be used.
Conditions Studied
Interventions
- DRUG Eflornithine placebo & sulindac placebo
- DRUG eflornithine & sulindac placebo
- DRUG Eflornithine placebo & sulindac
- DRUG Eflornithine plus sulindac
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Cancer Center at Saint Joseph's - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2013-08-23 |
| Est. Completion | 2032-02-01 |
| Phase | Phase 3 |
What the registry record for NCT01349881 still lists
NCT01349881 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 570-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Eflornithine placebo & sulindac placebo is the first listed.
NCT01349881 names 20 study sites across 5 states, led by Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01349881 about?
NCT01349881 is a clinical study titled "S0820, Adenoma and Second Primary Prevention Trial". The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.
What is the current status of trial NCT01349881?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 354 participants. The study started on 2013-08-23. Estimated completion is 2032-02-01.
What conditions does trial NCT01349881 study?
This clinical trial studies the following conditions: Colorectal Neoplasms.
What interventions are being tested in trial NCT01349881?
The interventions under investigation include: Eflornithine placebo & sulindac placebo (DRUG), eflornithine & sulindac placebo (DRUG), Eflornithine placebo & sulindac (DRUG), Eflornithine plus sulindac (DRUG).
Who is sponsoring clinical trial NCT01349881?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01349881 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01349881's enrollment target sits among peer trials
354 21st of 54 higher than 34 of 54 other Colorectal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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