What is the Purpose of this Study?
This study focuses on individuals who have been diagnosed with muscle-invasive bladder cancer and are considering bladder-preserving treatment with a combination of maximal tumor resection, chemotherapy and radiation therapy.
The purpose of the study is to examine the usefulness of implanting small (3 mm. x 1 mm.), 24-karat gold fiducial markers around the tumor site in the patient’s bladder so that the radiation oncologist can identify the original location of the patient’s tumor each day that they treat the bladder with radiation. The gold fiducial markers can generally be seen clearly during radiation treatment and are considered the best practice. These markers are used because the tumor site often does not show up well with conventional imaging during radiation treatment. Researchers will follow participants’ medical outcomes to determine whether implanting the markers improves how accurately the bladder/tumor site can be targeted (thereby avoiding radiation of organs or areas that should not be radiated).
Other goals of the study include assessing whether an imaging technology called mpMRI (high-resolution multi-parametric MRI) can help detect bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope. Additionally, researchers will explore whether mpMRI can distinguish between tumor recurrence versus scar-tissue in the bladder that can look like a tumor among patients who have already had radiation treatment and are now undergoing post-treatment follow-up imaging (“cancer surveillance”).
Eligibility
- * Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.
- * Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
- * Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation
- * Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min
Show more
Inclusion Criteria:
- * Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.
- * Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
- * Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation
- * Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min
- * Ability to understand and willingness to sign a written informed consent
- * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation
- * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Exclusion Criteria:
- * Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed
- * Known distant metastatic disease (e.g. pulmonary or hepatic metastases)
- * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed
- * Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)
- * Planned (or prior history of) definitive bladder irradiation
- * Intravesical chemo- or biologic therapy within 6 weeks of first treatment
- * Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion
- * Clinically significant active infection or uncontrolled medical condition that would preclude participation in study
- * Pregnant or nursing women are excluded
- * Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment
- * Individuals with severe renal failure and cannot receive MRI contrast
Show less
Where can I participate?
- CS Cancer at Cedars-Sinai Medical Center : Laura Sarmiento
- Massachusetts General Hospital (Study Affiliate)
- UCLA (Study Affiliate)
More about this Clinical Trial
What is the full name of this clinical trial?
IIT2017-12-GARCIA-FMBRT: Bladder Fiducial Markers and Multi-parametric-MRI to Optimize Bladder Chemo-radiotherapy