Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2014-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Laparoscopic radical cystectomy
Surgery: Laparoscopic radical cystectomy with open urinary diversion
Laparoscopic radical cystectomy with open urinary diversion
Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Open radical cystectomy
Surgery: Open radical cystectomy with open urinary diversion
Open radical cystectomy with open urinary diversion
Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Interventions
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Laparoscopic radical cystectomy with open urinary diversion
Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Open radical cystectomy with open urinary diversion
Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Eligibility Criteria
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Inclusion Criteria
2. Patients with an indication to ureterocutaneostomy or ileal conduit
3. ECOG Performance Status ≤ 2
4. WBC count ≥4,000/μL; platelet count ≥150,000/μL
4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Exclusion Criteria
2. Patients who have previously received any pelvic irradiation
3. Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
4. Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
5. Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
70 Years
MALE
No
Sponsors
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Responsible Party
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Pagliarulo Vincenzo
Medical Doctor
Principal Investigators
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Vincenzo VP Pagliarulo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Locations
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Vincenzo Pagliarulo
Bari, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Haber GP, Crouzet S, Gill IS. Laparoscopic and robotic assisted radical cystectomy for bladder cancer: a critical analysis. Eur Urol. 2008 Jul;54(1):54-62. doi: 10.1016/j.eururo.2008.03.076. Epub 2008 Apr 1.
Hemal AK. Robotic and laparoscopic radical cystectomy in the management of bladder cancer. Curr Urol Rep. 2009 Jan;10(1):45-54. doi: 10.1007/s11934-009-0009-8.
Edwards BK, Howe HL, Ries LA, Thun MJ, Rosenberg HM, Yancik R, Wingo PA, Jemal A, Feigal EG. Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer. 2002 May 15;94(10):2766-92. doi: 10.1002/cncr.10593.
Chamie K, Hu B, Devere White RW, Ellison LM. Cystectomy in the elderly: does the survival benefit in younger patients translate to the octogenarians? BJU Int. 2008 Aug;102(3):284-90. doi: 10.1111/j.1464-410X.2008.07636.x. Epub 2008 Apr 11.
Nielsen ME, Shariat SF, Karakiewicz PI, Lotan Y, Rogers CG, Amiel GE, Bastian PJ, Vazina A, Gupta A, Lerner SP, Sagalowsky AI, Schoenberg MP, Palapattu GS; Bladder Cancer Research Consortium (BCRC). Advanced age is associated with poorer bladder cancer-specific survival in patients treated with radical cystectomy. Eur Urol. 2007 Mar;51(3):699-706; discussion 706-8. doi: 10.1016/j.eururo.2006.11.004. Epub 2006 Nov 13.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Other Identifiers
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4201
Identifier Type: -
Identifier Source: org_study_id
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