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Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery
NCT00326898 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Sorafenib Tosylate
- DRUG Sunitinib Malate
Study Locations (20)
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
- Clearview Cancer Institute — Huntsville
- Mobile Infirmary Medical Center — Mobile
- Providence Hospital — Mobile
- University of South Alabama Mitchell Cancer Institute — Mobile
Arizona
- Banner Thunderbird Medical Center — Glendale
- Banner-University Medical Center Phoenix — Phoenix
- Western Regional CCOP — Phoenix
- Mayo Clinic in Arizona — Scottsdale
- Banner University Medical Center - Tucson — Tucson
Arkansas
- Sparks Regional Medical Center — Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
- University of Arkansas for Medical Sciences — Little Rock
- Highlands Oncology Group-Rogers — Rogers
California
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank
- Mills-Peninsula Medical Center — Burlingame
- East Bay Radiation Oncology Center — Castro Valley
Alaska
- Providence Alaska Medical Center — Anchorage
- Fairbanks Memorial Hospital — Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,943 participants |
| Start Date | 2006-04-24 |
| Est. Completion | 2021-09-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00326898
The ClinicalTrials.gov registry entry for NCT00326898 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 1,943 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Quality-of-Life Assessment 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: NCT00326898 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Alabama, 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 NCT00326898 about?
NCT00326898 is a clinical study titled "Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery". This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enz...
What is the current status of trial NCT00326898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,943 participants. The study started on 2006-04-24. Estimated completion is 2021-09-01.
What conditions does trial NCT00326898 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage II Renal Cell Cancer AJCC v7, Stage I Renal Cell Cancer AJCC v6 and v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00326898?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Sorafenib Tosylate (DRUG), Sunitinib Malate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00326898?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00326898 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.
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