Back to Clinical Trials

Brief Title: CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer

CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer

INTRODUCTION

  • Org Study ID: STUDY00006845
  • Secondary ID: PCS-2017C3-9380, RG1121143, NCI-2020-06082
  • NTC ID: NCT03933826
  • Sponsor: University of Washington

BRIEF SUMMARY

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

DETAILED DESCRIPTION

Most bladder cancer patients (74%) present with NMIBC where the cancer is limited to the lining or support layer of the bladder. High-grade NMIBC is treated initially with endoscopic resection and intravesical immunotherapy, followed by bladder instillations of BCG. Most patients with high-risk, high-grade NMIBC are able to retain their bladders and avoid more invasive treatments. However, 24-61% of patients will have their cancers recur within 12 months of treatment with BCG (BCG failures), and they have limited treatment options. National guidelines recommend consideration between two alternatives: additional medical management and radical cystectomy (removal of the bladder). Selecting between these options involves weighing the risk of progression of bladder cancer and loss of a window of potential cure versus the risk of morbidity and loss of quality of life (QOL) with bladder removal. This complex decision-making engages patients and their caregivers, who may be impacted by the urinary, sexual, and bowel dysfunctions that can occur with NMIBC treatment.

The investigators will evaluate this research question on a large scale in real world practice settings including academic and community-based practices and examine patient-centered outcomes. The investigators have engaged stakeholders with diverse perspectives relevant to this research question, including patients, caregivers, national patient advocacy organizations, national medical specialty organizations, guideline developers, health care payers, and industry. By engaging broad expertise relevant to this research question, the investigators will ensure that the study results will help NMIBC patients whose cancer recurs after BCG treatment make more informed decisions that improve the health outcomes that are important to them.

CISTO is an observational study that will not affect the treatment that patients chose. Patient surveys will occur at study entry and at follow-up assessments for up to four years. There will also be a qualitative sub-study that will include interviews of approximately 50 patients and 25 caregivers recruited from the observational cohort study.

  • Overall Status
    Recruiting
  • Start Date
    July 9, 2019
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)

Primary Outcome 1 - Timeframe: 12 months after completion of the patient baseline assessment

CONDITION

  • Bladder Cancer
  • Cancer of the Bladder
  • Recurrent
  • Non-muscle Invasive Bladder Cancer

ELIGIBILITY

Patient Eligibility, Inclusion Criteria:
Adult 18 years of age or older; and
Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
Pathology documentation from any hospital/clinic/medical center, and

- More than 50% urothelial carcinoma component in the specimen

- History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and

- Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; and

- In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.
Patient Eligibility, Exclusion Criteria:
Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);

- Previous history of cystectomy or radiation therapy for bladder cancer;

- Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;

- Any history of upper tract urothelial carcinoma;

- Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;

- Contraindication to radical cystectomy (e.g., ASA of 4);

- Contraindication to medical therapy (i.e., intolerant of all medical therapies);

- Unable to provide written informed consent in English;

- Unable to be contacted for research surveys;

- Planning to participate in a Phase I or Phase II interventional clinical trial for NMIBC or any blinded interventional trial for NMIBC.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: N/A

OFFICIAL INFORMATION

Name: John L Gore, MD

Role: Principal Investigator

Affiliation: University of Washington

Overall Contact

Name: John L Gore, MD

Phone: 206-685-8708, 206-221-3174

Email: cistopm@uw.edu, ewolff2@uw.edu

LOCATION

Facility Status Contact
Facility: University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Status: Recruiting Contact: Contact
Mary Jane Avant
855-776-0015 32848
mavant@uabmc.edu
Facility: Mayo Clinic Cancer Center
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Principal Investigator
Jeffrey Nix, MD
949-557-0290
ileana.aldana@med.usc.edu
Facility: USC/Norris Comprehensive CA Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Clinical Trials Office
773-795-8513
Nohely.Aldana@med.usc.edu
Facility: UCLA
Los Angeles, California 90095
United States
Status: Recruiting Contact: Principal Investigator
Mark Tyson, MD, MPH
773-702-1835
kcwilliams@mednet.ucla.edu
Facility: Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Status: Recruiting Contact: Contact
Ileana Aldana
319-467-5833
sconnor@mednet.ucla.edu
Facility: H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United States
Status: Recruiting Contact: Contact
Nohely Aldana
410-502-8346
atessa.kiana@hoag.org
Facility: Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Principal Investigator
Sia Daneshmand, MD
410-955-0009
leila.andres@hoag.org
Facility: University of Chicago
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Kristen Wallace, MA
212-342-5162
Rebecca.Alexander@moffitt.org
Facility: University of Iowa
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Sarah Connor, MPH
980-442-2000
katya.bobrek@emory.edu
Facility: Johns Hopkins University, School of Medicine
Baltimore, Maryland 21231
United States
Status: Recruiting Contact: Principal Investigator
Karim Chamie, MD, MSPH
704-355-8686
misaki.mason@emory.edu
Facility: Chesapeake Urology Research Associates
Hanover, Maryland 21076
United States
Status: Recruiting Contact: Contact
Atessa Kiani
405-271-8001
modi@bsd.uchicago.edu
Facility: Michigan Medicine Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact
Leila Andres
704-241-2185
rblukas@medicine.bsd.uchicago.edu
Facility: Spectrum Health
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Principal Investigator
Jeffrey Bassett, MD
214-645-8482
laura-jacobus@uiowa.edu
Facility: Albert Einstein College of Medicine
Bronx, New York 10461
United States
Status: Recruiting Contact: Contact
Rebecca Alexander
214-645-8103
francesca-nugent@uiowa.edu
Facility: Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
United States
Status: Recruiting Contact: Principal Investigator
Scott Gilbert, MD

cisto@jhmi.edu
Facility: University of North Carolina
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Katya Bobrek, BS

cisto@jhmi.edu
Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: Contact
Misaki Mason

wpaxton@chesuro.com
Facility: The Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Principal Investigator
Viraj Master, MD, PhD

bkyei@chesuro.com
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73114
United States
Status: Recruiting Contact: Contact
Parth Modi, MD, MS

dcovalsc@med.umich.edu
Facility: Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Status: Recruiting Contact: Contact
Rachael Lukas, MS

perryste@med.umich.edu
Facility: Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Status: Recruiting Contact: Principal Investigator
Parth Modi, MD, MS

zachary.mulder@spectrumhealth.org
Facility: Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19122
United States
Status: Recruiting Contact: Contact
Laura Jacobus

ross.busman@spectrumhealth.org
Facility: Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Francesca I Nugent, BA

johor@montefiore.org
Facility: Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Principal Investigator
Kenneth Nepple, MD

cancerclinicaltrials@cumc.columbia.edu
Facility: Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: Contact
N. Biafra Okoronkwo

dana_mueller@med.unc.edu
Facility: UT Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Sandy Moore-Cooper

alicia.patrick@atriumhealth.org
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Principal Investigator
Trinity Bivalacqua, MD, PhD

Stephen.Riggs@atriumhealth.org
Facility: The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Wendy Paxton, CCRC

lindsay.hanes@osumc.edu
Facility: University of Utah
Salt Lake City, Utah 84132
United States
Status: Recruiting Contact: Contact
Barbara Kyei

donnice-smith@ouhsc.edu
Facility: University of Washington
Seattle, Washington 98195
United States
Status: Recruiting Contact: Principal Investigator
Rian Dickstein, MD

riza-fabero@ouhsc.edu