NCT00509704

Brief Summary

The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

November 9, 2010

Status Verified

October 1, 2010

First QC Date

July 30, 2007

Last Update Submit

November 8, 2010

Conditions

Renal Cell Cancer

Keywords

Sutenttumor necrosisDCE-MRI (Dynamic enhanced magnetic resonance imaging)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a malignant abdominal tumor or metastases (minimal diameter 2 cm)

You may qualify if:

  • patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned
  • histologically verified stage IV renal cell carcinoma of clear cell type
  • measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs
  • Karnofsky score \> 70%
  • age \> 18 year.
  • written informed consent

You may not qualify if:

  • contra-indications for MRI
  • contra-indications for treatment with Sunitinib
  • previous systemic treatment within the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC St Radboud

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • C.M.L. van Herpen, MD, PhD

    UMC St Radboud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

October 1, 2008

Study Completion

May 1, 2010

Last Updated

November 9, 2010

Record last verified: 2010-10

Locations

NL(1)