Retrospective Chart Review of Valstar
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Purpose
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.
| Condition |
|---|
|
Carcinoma in Situ of Bladder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice |
- Event-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]Event-free survival defined as recurrence, progression or death from any cause
- Worsening-free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause
| Enrollment: | 113 |
| Study Start Date: | March 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG. Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. The recommended course of therapy is 6 doses of 800 mg each administered intravesically once a week. While the benefit risk profile of valrubicin has been established in several clinical trials, current data on effectiveness and tolerability when used in clinical practice are lacking. This protocol outlines a retrospective study to evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the treatment of NMIBC in a clinical practice setting.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients who have been treated with valrubicin in a clinical practice setting.
Inclusion Criteria:
- age 18 years old or greater
- diagnosis of CIS (physician defined in the medical record)
- treated with at least one IVe dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment
- willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A 46.117
Exclusion Criteria:
- route of administration of valrubicin other than intravesical
Contacts and Locations More Information
No publications provided
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01304173 History of Changes |
| Other Study ID Numbers: | EN3329-401 |
| Study First Received: | February 23, 2011 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Endo Pharmaceuticals:
|
BCG refractory NMIBC CIS non-muscle invasive |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma in Situ Urinary Bladder Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013