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A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer


Phase 4
N/A
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer


The Statistical Analysis Plan provides detailed specification of the analysis


Inclusion Criteria:



- First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria:

- Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of Participants With Categorical Best Overall Response

Outcome Description:

Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

Outcome Time Frame:

Start of Treatment up through 12 Months or Early Discontinuation

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

A6181115

NCT ID:

NCT00460798

Start Date:

February 2007

Completion Date:

September 2009

Related Keywords:

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

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