Chemoradiation for Bladder Preservation in Patients With Muscle Invasive Bladder Carcinoma After Complete Response to Neoadjuvant Chemotherapy
Conditions
Bladder Cancer - Bladder Carcinoma - Transition Cell Cancer - Muscle Invasive Bladder Carcinoma
Conditions: official terms
Carcinoma - Urinary Bladder Neoplasms
Conditions: Keywords
Bladder Cancer, Bladder Carcinoma, Transition Cell Cancer, TCC, Muscle Invasive Bladder Carcinoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Transurethral Resection of the Bladder Tumor & Cystoscopy Type: Procedure
Name: Cisplatin Type: Drug
Name: Gemcitabine Type: Drug
Name: Intensity Modulated Radiation Therapy Type: Radiation
Name: Quality of Life Questionnaires Type: Behavioral
Name: Urine Collection for Molecular Analysis Type: Genetic
Name: Blood Collection for Molecular Analysis Type: Genetic
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pathologically proven diagnosis of primary carcinoma of the bladder(transitional cell cancer). Must be operable patients with muscularis propria invasion and 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.

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

- Zubrod Performance Status of ≤1.

- Age ≥18.

- CBC/differential obtained no more than 8 weeks prior to enrollment on study, with adequate bone marrow function defined as follows:

- 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)

- Serum bilirubin of 2.0mg or less;

- 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.)

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

Exclusion Criteria:

- Tumor related untreated active hydronephrosis

- Evidence of distant metastases.

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

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

- 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

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

- 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

- 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 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
Location
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Status: Recruiting
Contact: Adrian S Ishkanian, MD - 786-243-5454 - a.ishkanian@med.miami.edu
Start Date
June 2014
Sponsors
University of Miami
Source
University of Miami
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page