Status:
UNKNOWN
Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery
Lead Sponsor:
N.N. Petrov National Medical Research Center of Oncology
Collaborating Sponsors:
The Foundation for Cancer Research Support (RakFond)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. Ther...
Eligibility Criteria
Inclusion
- histologically confirmed diagnosis of very high risk non muscle-invasive bladder carcinoma (cT1NoMo) or muscle-invasive bladder carcinoma (cT2-T4NxM0) with or without neoadjuvant therapy (chemotherapy or immunotherapy are both possible);
- patient should be eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy or hysterectomy if applicable) according to surgeon opinion;
- pelvic lymph node dissection is engaged in two possible variants: extended level to intersection of ureter and iliac vessels; superextended level - up to aortic bifurcation;
- urinary diversion is engaged in two possible variants: orthotopic diversion (J- or U-pouch reservoirs), heterotopic diversion in the Mainz-I modification, Bricker;
- male or female is at least 18 years old at the time of signing the informed consent form;
- female patient is eligible to participate if she is not pregnant, not breastfeeding;
- ECOG performance status of 0 or 1;
- adequate organ function (in accordance with laboratory standards);
- used valid protocol for Enhanced Recovery After Surgery (ERAS protocol) at Hospital (oncourological department);
Exclusion
- known additional non-urothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions;
- diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug;
- replacement doses of corticosteroids are permitted for participants with adrenal insufficiency;
- evidences of uncontrolled diseases (diabetes mellites, noninfectious pneumonitis that required steroids, et.) or any conditions which interfere with the conduct of the research procedures according to doctor opinion;
- presence of 2 or more criteria for systemic inflammatory response syndrome (SIRS) at the time of the patient's admission to the hospital (assessment of these factors 3-7 days before randomization):
- temperature ≥ 38˚С or ≤ 36˚С;
- heart rate (HR) ≥ 90 / min;
- respiratory rate \< 20/min or hyperventilation (Pa CO2 ≤ 32 mm Hg);
- blood leukocytes \>12 ∙ 109 / l or \< 4 ∙ 109 / l, or immature forms \> 10%
- prohibited urinary diversion when planning surgery and signing voluntary consent: diversion into continuous intestine (ureterosigmostomy, Mainz-pouch II operation);
- inadequate organ function:
- Neutrophils \<1.5 x 10 \^ 9 / l
- Platelets \<100 x 10 \^ 9 / l
- ALT\> 3 x VGN
- AST\> 3 x VGN
- Bilirubin\> 1.5 x ULN
- GFR level \<35 ml / min
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05392634
Start Date
February 2 2022
End Date
November 1 2023
Last Update
May 31 2022
Active Locations (1)
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1
FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
Saint Petersburg, Sankt-Peterburg, Russia, 197758