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ACTIVE NOT RECRUITING Phase 3

S0820, Adenoma and Second Primary Prevention Trial

NCT01349881 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 354 participants
Start Date 2013-08-23
Est. Completion 2032-02-01
Phase Phase 3

Sponsor

SWOG Cancer Research Network

212 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01349881

The ClinicalTrials.gov registry entry for NCT01349881 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01349881 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Alaska, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01349881?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial