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BRIEF TITLE: Chemoradiation for Bladder Preservation in Patients With Muscle Invasive Bladder Carcinoma After Complete Response to Neoadjuvant Chemotherapy

A Phase II Study of Chemoradiation for Bladder Preservation in Patients With Muscle Invasive Bladder Carcinoma After Complete Response to Neoadjuvant Chemotherapy


  • Org Study ID: 20130896
  • Secondary ID:
  • NCT ID: NCT02145390
  • NCT Alias:
  • Sponsor: University of Miami - Other
  • Source: University of Miami

Brief Summary

Bladder preservation in patients with complete response after neoadjuvant chemotherapy will lead to equivalent or superior relapse free rates compared to cystectomy rates from historical controls.

Detailed Description


1. Transurethral Resection of the Bladder Tumor (TURBT) and Cystoscopy performed by
participating urologist:

- cystoscopic evaluation

- bimanual examination under anesthesia,

- as thorough as possible a transurethral resection (TUR) of the bladder tumor,

- and a biopsy of the prostatic urethra including both mucosa and stroma using a
resection loop.

2. Neoadjuvant Chemotherapy, per standard of care: All patients will receive the
neoadjuvant course of chemotherapy. The recommended neoadjuvant chemotherapy regimen
consists of Gemcitabine and Cisplatin given on a 21-day cycle.This regimen will begin
within 8 weeks following the TURBT and cystoscopic evaluation by the urologic surgeon;

3. Post-Neoadjuvant Evaluation: This evaluation will take place ≤ 6 weeks following the
completion of the neoadjuvant chemotherapy. Evaluation will include:

- urine cytology,

- cystoscopy,

- tumor site transurethral biopsy,

- and bimanual examination after biopsy

- and biopsy of TURBT site

4. For subjects with complete response to neoadjuvant chemotherapy: Chemoradiation within 6
weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy
(IMRT/VMAT), and concurrent Cisplation therapy, per standard of care; OR

5. For subjects with pT1 or worse tumor response to neoadjuvant chemotherapy: Radical
Cystectomy within 12 weeks after post-neoadjuvant evaluation;

6. Post-Consolidation Endoscopic Evaluations: The first post-treatment evaluation will be
30 days +/- 14 days within the end of chemoradiation, surgery or at progression.
Subsequent cystoscopic evaluation will be every three months in the first year, every
four months in the second year, and every six months in the third year (all evaluations
to occur +/- 14 days). Each evaluation will include serum, plasma, whole blood, urine
cytology.

Overal Status Start Date Phase Study Type
Recruiting January 5, 2016 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Rate of Failure-Free Survival with Intact Bladder (FFSIB) in Study Participants

Primary Outcome 1 - Time Frame: 2 years

Condition:

  • Bladder Cancer
  • Bladder Carcinoma
  • Transition Cell Cancer
  • Muscle Invasive Bladder Carcinoma

Eligibility

Criteria:
Inclusion Criteria:

1. Pathologically proven diagnosis of primary carcinoma of the bladder(transitional cell
cancer). Must be operable patients with muscularis propria invasion and American Joint
Committee on Cancer (AJCC) clinical stages T2-4a, N0 or N+, M0. Patients with
prostatic urethra involvement with transitional cell cancer (TCC) are eligible if it
is completely resected and the patient has no evidence of stromal invasion of the
prostate.

2. Patients must be able to tolerate systemic chemotherapy combined with pelvic radiation
therapy and radical cystectomy.

3. Zubrod Performance Status of ≤1.

4. Age ≥18.

5. Complete Blood Count (CBC)/differential obtained no more than 8 weeks prior to
enrollment on study, with adequate bone marrow function defined as follows:

- White Blood Cell (WBC) ≥ 4000/ml

- Absolute neutrophil count (ANC) ≥1,800 cells/mm

- Platelets ≥100,000 cells/mm

- Hemoglobin ≥ 10.0 mg/dl (Note: the use of transfusion or other intervention to
achieve this level is acceptable)

6. Serum bilirubin of 2.0mg or less;

7. Serum creatinine of 1.5mg or less; creatinine clearance of 60ml/min or greater no more
than 8 weeks prior to enrollment (Note: calculated creatinine clearance is
permissible, using Cockcroft-Gault formula. If the creatinine clearance is greater
than 60ml/min, then a serum creatinine of up to 1.8mg is allowable at the discretion
of the principal investigator.)

Note: Prechemotherapy laboratory investigations and Eastern Cooperative Oncology Group
(ECOG) evaluation must meet inclusion criteria irrespective of where they were drawn,
retroactive, prior to cycle 1 of cisplatin/gemcitabine. Inclusion criteria from these
initial investigations will be used for evaluation of enrollment eligibility.

8. Patients must be willing and able to provide study-specific informed consent prior to
study entry

Exclusion Criteria:

1. Tumor related untreated active hydronephrosis

2. Evidence of distant metastases.

3. Diffuse bladder carcinoma in situ (CIS) not able to be encompassed in a boost
radiotherapy volume.

4. Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy

5. A prior or concurrent malignancy of any other site or histology unless the patient has
been disease free for greater than or equal to five years except for non-melanoma skin
cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix

6. Patients that are not candidates for radical cystectomy (T4b disease are considered
unresectable)

7. Pregnancy or women of childbearing potential [not post-menopausal or permanently
sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy)] and men who
are sexually active and not willing/able to use medically acceptable forms of
contraception; this exclusion is necessary because the treatment involved in this
study may be significantly teratogenic

8. Severe active co-morbidity:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of enrollment

- History of hepatic insufficiency resulting in clinical jaundice and/or
coagulation defects (Note: laboratory tests for liver function and coagulation
parameters are not required for enrollment into this protocol)

- Known diagnosis of Acquired Immune Deficiency Syndrome (AIDS) based upon current
Centers for Disease Control (CDC) definition (Note: HIV testing is not required
for enrollment into this protocol). The need to exclude patients with AIDS from
this protocol is necessary because the treatments involved in this protocol may
be significantly immunosuppressive.

- As determined by the investigator or principal investigator
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Adrian S Ishkanian, MD

Role: Principal Investigator

Affiliation: University of Miami Sylvester Comprehensive Cancer Center

Location

Facility Status Contact
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Recruiting Adrian S Ishkanian, MD
786-243-5454
a.ishkanian@med.miami.edu