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Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer

NCT01099423 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2017-02-08

No results posted yet for this study

Summary

RATIONALE: Sunitinib malate 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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether undergoing immediate surgery or surgery after sunitinib malate is more effective in treating patients with metastatic kidney cancer.

PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it works compared with surgery after sunitinib malate in treating patients with metastatic kidney cancer.

Conditions

Interventions

PROCEDURE

timing of surgery

GENETIC

gene expression analysis

OTHER

biologic sample preservation procedure

OTHER

laboratory biomarker analysis

PROCEDURE

therapeutic conventional surgery

Sponsors & Collaborators

  • Wales Cancer Trials Unit

    collaborator OTHER

  • Canadian Urologic Oncology Group

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Axel Bex · The Netherlands Cancer Institute

  • John B.A.G. Haanen · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-04-30
Completion
2017-05-31

Countries

  • Belgium
  • Canada
  • Italy
  • Netherlands
  • United Kingdom

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 NCT01099423 on ClinicalTrials.gov