Brief Title
Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma
Official Title
A Single Arm Phase II Trial of the Intraoperative Intravesical Instillation of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
Brief Summary
Results of previous studies suggest that the timing of intravesical mitomycin C
administration may impact bladder tumor recurrence rate following radical nephroureterectomy.
This is the first study of its kind to attempt to identify the importance of timing of
mitomycin C administration relative to bladder tumor recurrence rate following radical
nephroureterectomy.This study will investigate the one year bladder tumor recurrence rate in
patients with urothelial carcinoma of the upper urinary tract following intraoperative
administration of mitomycin C during a nephroureterectomy, as well as the time to bladder
tumor recurrence in this patient population.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Bladder Tumor Recurrence Rate
Secondary Outcome
Time to Bladder Tumor Recurrence
Condition
Urothelial Carcinoma
Intervention
Mitomycin c
Study Arms / Comparison Groups
Mitomycin C
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
December 5, 2018
Completion Date
September 2023
Primary Completion Date
November 10, 2021
Eligibility Criteria
Inclusion Criteria:
- Both males and females ≥ eighteen years of age
- Clinical diagnosis of urothelial carcinoma of the renal pelvis and/or ureter. Clinical
diagnosis of urothelial carcinoma may be based upon radiographic, pathologic or
cytological findings alone or in combination with one another. No other histology is
allowed.
- The TNM stage of the subject's disease (using the American Joint Committee on Cancer
[AJCC] Cancer Staging Manual, 8th Edition) must be Tis, Ta, T1, T2, or T3, N0, M0.
Subjects may have either a high-grade or low-grade tumor.
- ECOG performance status of 0-2
- Written informed consent obtained from the subject and the ability for the subject to
comply with all the study-related procedures.
- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy prior to and for at least 3 months after mitomycin C
instillation to minimize the risk of pregnancy. Prior to study enrollment, women of
childbearing potential must be advised of the importance of avoiding pregnancy during
trial participation and the potential risk factors for an unintentional pregnancy.
- Males with female partners of child-bearing potential must agree to use
physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) should
avoid conceiving children prior to and for 3 months following mitomycin C instillation
- Subjects must have hemoglobin ≥ 9 g/dL and a platelet count ≥ 100,000/μL.
Exclusion Criteria:
- Active urothelial carcinoma of the bladder within 12 months prior to enrollment
- History of adverse reaction to mitomycin C
- Evidence of regional or metastatic disease.
- History of radical cystectomy
- Planned radical cystectomy at the time of nephroureterectomy
- Females or males of childbearing potential who are unwilling or unable to use an
acceptable method to avoid pregnancy prior to and for at least 3 months after
mitomycin C instillation.
- Females who are pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of protocol therapy or that might affect the interpretation of
the results of the study or that puts the subject at high risk for treatment
complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical illness.
- Subjects demonstrating an inability to comply with the study and/or follow-up
procedures
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Paul Crispen, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03658304
Organization ID
UF-GU-001
Secondary IDs
OCR18677
Responsible Party
Sponsor
Study Sponsor
University of Florida
Study Sponsor
Paul Crispen, MD, Principal Investigator, University of Florida
Verification Date
December 2022