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

NCT00326898 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1943

Last updated 2022-02-08

Study results available
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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

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Sorafenib Tosylate

Given PO

DRUG

Sunitinib Malate

Given PO

Sponsors & Collaborators

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Naomi S Balzer-Haas · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-24
Primary Completion
2015-08-27
Completion
2021-09-01

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00326898 on ClinicalTrials.gov