Open Versus Laparoscopic Radical Cystectomy

Bladder Cancer Clinical Trial

— OvsL  

Official title:

Open Versus Laparoscopic Radical Cystectomy for Invasive Bladder Cancer in the Elderly Patient. A Multicenter Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02345499
• Other study ID #: 4201
• Status: Recruiting
• Phase: Phase 2
• First received: January 14, 2015
• Last updated: January 19, 2015
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Azienda Ospedaliero-Universitaria Consorziale
• Contact: Vincenzo VP Pagliarulo, M.D.
• Phone: +39 080 5595228
• Email: vpagliarulo[@]urologia.uniba.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder

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:

1. Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit)

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Italy	Vincenzo Pagliarulo	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Hemal AK. Robotic and laparoscopic radical cystectomy in the management of bladder cancer. Curr Urol Rep. 2009 Jan;10(1):45-54. Review. — View Citation

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. Epub 2006 Nov 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.	24 months	Yes
Secondary	Health related quality of life	Comparison of health related quality of life among the two cohorts under investigation according to the SF-36 questionnaire	24 months	No