Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)

NCT04947059 | Recruiting Phase 3

• 1 other identifier: 11006/28.04.2021
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The natural history of non-muscle-invasive bladder cancer is characterised by recurrence and progression. We compare the effectiveness of gemcitabine hydrochloride and epirubicin hydrochloride, in combination with continuous saline irrigation, as an immediate single intravesical instillation in the potential reduction of the disease recurrence as well as progression.

Conditions

Bladder Cancer

Keywords

Postoperative intravesical instillation; Gemcitabine; Epirubicin

Outcome Measures

Primary Outcomes (4)

• Bladder cancer recurrence

  Histologically proven bladder cancer recurrence

  At 3 months after the transurethral resection of a bladder tumor

• Bladder cancer progression

  Histologically proven bladder cancer progression

  At 3 months after the transurethral resection of a bladder tumor

• Bladder cancer recurrence

  Histologically proven bladder cancer recurrence

  At 12 months after the transurethral resection of a bladder tumor

• Bladder cancer progression

  Histologically proven bladder cancer progression

  At 12 months after the transurethral resection of a bladder tumor

Secondary Outcomes (2)

• Bladder cancer recurrence

  At 24 months after the transurethral resection of a bladder tumor

• Bladder cancer progression

  At 24 months after the transurethral resection of a bladder tumor

Study Arms (2)

Gemcitabine

ACTIVE COMPARATOR

Bladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with gemcitabine hydrochloride 2gr in 100ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours

Drug: Gemcitabine Hydrochloride combined with continuous saline irrigation

Epirubicin

ACTIVE COMPARATOR

Bladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with epirubicine hydrochloride 50mg in 50ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours

Drug: Epirubicin Hydrochloride combined with continuous saline irrigation

Interventions

Gemcitabine Hydrochloride combined with continuous saline irrigation DRUG

Immediate single intravesical instillation with gemcitabine combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor

Also known as: GROUP A

Gemcitabine

Epirubicin Hydrochloride combined with continuous saline irrigation DRUG

Immediate single intravesical instillation with epirubicin combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor

Also known as: GROUP B

Epirubicin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary urinary bladder tumor
• Secondary urinary bladder tumor (recurrence)
• Bipolar or monopolar resection
• Creat \<2.2mg/dl
• % \<Hct \<52%
• White bloode cells count WBC ≥3000 / μL
• \<PLT \<500000 / μL
• Urine culture: negative / sterile
• Alkaline phosphatase, total bilirubin, SGOT, SGPT: values as high as 2 times above the upper normal limit
• Good clinical condition (according to Eastern Cooperative Oncology Group PS ≤ 1)
• CT Urography without findings suggesting an upper urinary tract tumor in the last 3 months before the transurethral resection of the bladder tumor

You may not qualify if:

• More than 2 low grade / high differentiation (low grade / LG) histologically confirmed bladder tumors in the last 18 months before the transurethral resection of the bladder tumor
• High grade / low differentiation (HG) histologically confirmed bladder tumor in the last 9 months before the transurethral resection of the bladder tumor
• Those who undergo a transurethral resection of a bladder tumor according to the Guidelines of the European Association of Urology for non-muscle-invasive bladder cancer: incomplete resection of tumor, absence of muscle fibers in the sample with the exception of: Ta / LG-G1, primary Cis and finally, pT1 tumors
• Intravesical instillation of chemotherapeutic agent or BCG in the last 6 months before the transurethral resection of the bladder tumor
• History of non-urothelial bladder cancer
• Stage of disease pT2 (muscle-invasive bladder cancer)
• Presence of a tumor in the urethra
• Upper urinary tract malignancy (present or anamnestically)
• History of pelvic radiotherapy
• Histrory of another malignancy in the last 5 years before the transurethral resection of the bladder tumor

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Urology Department, University of Thessaly, University Hospital of Larissa

Larissa, Larissa/Thessaly, 41110, Greece

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Vasileios Tzortzis, Professor

  Urology Department, University of Thessaly, University Hospital of Larissa, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasileios Tzortzis, Professor

CONTACT

00302413502811; urologydpt.uth@gmail.com

Lampros Mitrakas, Consultant

CONTACT

00302413501325; lamprosmit@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Bladder cancer patients, who are treated with a transurethral resection of the bladder tumor, receive postoperatively an immediate single intravesical instillation with either gemcitabine hydrochloride or epirubicine hydrochloride

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 1, 2021
• Study Start: December 14, 2021
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After a publication and for a period of 2 years

Locations

GR (1)