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Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey


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Not Enrolling
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Renal Cell Carcinoma

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Trial Information

Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey


Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting
clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in
Chinese patients with renal cell carcinoma were deficiency. The investigators carried out
this research project will be sufficient evidence, and help clinicians in China to make
decision in real daily practice.


Inclusion Criteria:



- Histologically or cytologically confirmed, unresectable advanced renal cell
carcinoma;

- Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion Criteria:

- History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Disease control rate (DCR)

Outcome Description:

To determine the Disease control rate (DCR) defined as the percentage of patients who have a partial response (CR) or complete response (PR) to Sunitinib plus those whose disease is stable (DS). To determine the Objective Responsive Rate (ORR) defined as the percentage of patients who have a partial response (PR) or complete response (CR) to Sunitinib.

Outcome Time Frame:

2008-2011 (up to 3 years)

Safety Issue:

No

Principal Investigator

Zhangqun Ye, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tongji Hospital

Authority:

China: Food and Drug Administration

Study ID:

CFC20110815

NCT ID:

NCT01441661

Start Date:

November 2007

Completion Date:

June 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Sunitinib
  • kidney diseases
  • urogenital neoplasms
  • kidney cancer
  • Carcinoma
  • Carcinoma, Renal Cell

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