Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk factors for tumor recurrence.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIPEC after Radical Cystectomy | Experimental | After completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIPEC | Procedure | 40mg of Mitomycin-C dissolved in 100ml normal saline will be added into the perfusate and instilled into the patient for a total of 60 minutes. After 60 minutes, the abdomen will be irrigated with 3 liters of normal saline. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment toxicity | Treatment toxicity will be analyzed using NCI Common Terminology Criteria for Adverse Events-Version 4.0. Descriptive statistics will be used to determine proportion of grade III/V treatment toxicity. Expected grade III/V toxicity in surgical patients without HIPEC would be 3 out of 10 patients. With the addition of HIPEC, there would be a significant difference (p=0.05) if 6 out of 10 patients experienced a grade III/V toxicity. Therefore, if less than 6 patients experience a grade III/V we would consider this a "negative" finding. | 90 days |
Not provided
Not provided
Inclusion Criteria:
Primary urothelial cell carcinoma of the bladder
Patient's aged 45-85, both genders.
ECOG performance status < 1
Hematology: ANC > 1.5x109/L; Platelets > 100x109/L
Women with child bearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
Either any of the following preoperative factors for increased risk of recurrence:
Lymphovascular invasion
Variant histology in the background of primary urothelial (notably plasmacytoid)
Clinical T3 or greater
Clinical N+
No prior neoadjuvant chemotherapy (NAC) or lack of response to NAC
Or any of the following perioperative factors for increased risk of recurrence:
Palpable concern for extravesical disease
Tumor spillage/bladder entry
Suspicious nodes or positive intraoperative frozen sections
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas S Scherr, MD | Weill Cornell Medicine - New York Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine - New York Presbyterian Hospital | New York | New York | 10065 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided
HIPEC with Mitomycin-C
Not provided
Not provided
Not provided
Not provided
|
| D006979 |
| Hyperthermia, Induced |