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Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
NCT00002716 · View on ClinicalTrials.gov ↗
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer.
Conditions Studied
Interventions
- DRUG dexamethasone
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG floxuridine
- PROCEDURE laparotomy
Study Locations (14)
Iowa
- CCOP - Cedar Rapids Oncology Project — Cedar Rapids
- CCOP - Iowa Oncology Research Association — Des Moines
- John Stoddard Cancer Center at Iowa Methodist Medical Center — Des Moines
- Mercy Cancer Center at Mercy Medical Center-Des Moines — Des Moines
- Iowa Lutheran Hospital — Des Moines
Pennsylvania
- Penn State Cancer Institute at Milton S. Hershey Medical Center — Hershey
- Fox Chase Cancer Center — Philadelphia
Other
- Instituto de Enfermedades Neoplasicas — Lima
- San Juan City Hospital — San Juan
Nebraska
- Midlands Cancer Center at Midlands Community Hospital — Papillion
New Mexico
- MBCCOP - University of New Mexico HSC — Albuquerque
Ohio
- MetroHealth Medical Center — Cleveland
Wisconsin
- CCOP - St. Vincent Hospital Cancer Center, Green Bay — Green Bay
New South Wales
- Westmead Hospital — Westmead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 1996-01 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002716
The ClinicalTrials.gov registry entry for NCT00002716 describes a study currently listed as completed. 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 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which dexamethasone 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: NCT00002716 reports 14 study locations spanning 8 distinct geographic areas — top geographies include Iowa, Pennsylvania, Other. 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 NCT00002716 about?
NCT00002716 is a clinical study titled "Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer. PURPOSE: Randomized pha...
What is the current status of trial NCT00002716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 1996-01. Estimated completion is 2006-08.
What conditions does trial NCT00002716 study?
This clinical trial studies the following conditions: Colorectal Cancer, Metastatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00002716?
The interventions under investigation include: dexamethasone (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), floxuridine (DRUG), laparotomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00002716?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00002716 being conducted?
This trial has 14 study locations across Iowa, Nebraska, New Mexico, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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