Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma
This study has been completed.
Sponsor:
Cancer Foundation, China
Collaborator:
Pfizer
Information provided by (Responsible Party):
Cancer Foundation, China
ClinicalTrials.gov Identifier:
NCT01441661
First received: September 26, 2011
Last updated: March 15, 2013
Last verified: September 2007
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Purpose
This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.
| Condition |
|---|
|
Renal Cell Carcinoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey |
Resource links provided by NLM:
Further study details as provided by Cancer Foundation, China:
Primary Outcome Measures:
- Disease control rate (DCR) [ Time Frame: 2008-2011 (up to 3 years) ] [ Designated as safety issue: No ]
- 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.
Secondary Outcome Measures:
- Progression Free survival (PFS) [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: No ]• To assess the Progression Free survival (PFS) as defined by time interval from date of first dose of Sunitinib to date of the progression of cancer or date of death due to any reasons whichever appears earlier.
- Overall Survival (OS) [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: No ]• To evaluate Overall Survival (OS) as defined by time interval from date of first dose of Sunitinib to date of death due to any reason.
- Number of patients with adverse events [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: Yes ]• To evaluate Safety of Sunitinib. Adverse events were graded according to the National Cancer Institute issued the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
| Enrollment: | 400 |
| Study Start Date: | November 2007 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Sunitinib Renal Cell Carcinoma
Patients diagnosed with Renal Cell Carcinoma (RCC) and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed with RCC and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441661
Locations
| China, Beijing | |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | |
| Beijing, Beijing, China, 100021 | |
| China, Hubei | |
| Tongji Hospital, Tongji Medical College of Hust | |
| Wuhan, Hubei, China, 430030 | |
Sponsors and Collaborators
Cancer Foundation, China
Pfizer
Investigators
| Principal Investigator: | Zhangqun Ye, MD | Tongji Hospital, Tongji Medical College of HUST |
More Information
No publications provided
| Responsible Party: | Cancer Foundation, China |
| ClinicalTrials.gov Identifier: | NCT01441661 History of Changes |
| Other Study ID Numbers: | CFC20110815 |
| Study First Received: | September 26, 2011 |
| Last Updated: | March 15, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Cancer Foundation, China:
|
Sunitinib kidney diseases urogenital neoplasms kidney cancer |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013