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NCT00326898 · ClinicalTrials.gov registry record · Phase 3

Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

A Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
1,943
Enrollment target
20
Study locations

NCT00326898 is a Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,943 participants, above the 160-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (1114% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00326898, a Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
1,943 participants
Enrollment target
20
Study locations

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.

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

FieldValue
Enrollment Target 1,943 participants
Start Date 2006-04-24
Est. Completion 2021-09-01
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00326898

The ClinicalTrials.gov registry entry for NCT00326898 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,943 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 160-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (1114% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT00326898 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alabama, Arizona, Arkansas.

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.

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).

Who is sponsoring clinical trial NCT00326898?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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

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