Prophylactic Intravesical Chemotherapy After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Randomized Controlled Trial Between Single Postoperative Dose Versus Maintenance Therapy.

NCT02438865 | Completed Phase 2 DMC

• 1 other identifier: MElsh112015
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is designed to compare the effect of single postoperative intravesical chemotherapy instillation versus maintenance therapy on reducing bladder cancer recurrence after surgery for UTUC.

Conditions

Neoplasm, Ureter; Neoplasm, Bladder

Keywords

Upper Tract Urothelial Carcinoma; Intravesical Chemotherapy; Epirubicin; Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• bladder recurrence

  The primary outcome of the study is the diagnosis of intravesical recurrence within the first year after surgery.

  1 year after surgery

Secondary Outcomes (1)

• adverse events

  1 year after surgery

Study Arms (2)

Single instillation group

ACTIVE COMPARATOR

will receive single intravesical dose of epirubicin intravesical therapy (50 mg) within 48 hours of radical nephroureterectomy with open bladder cuff excision.

Drug: Immediate instillation of intravesical chemotherapy-Epirubicin-

Maintainance therapy group

ACTIVE COMPARATOR

will receive a single intravesical dose of epirubicin and an additional 6 weekly doses of intravesical therapy (50 mg) after surgery then monthly maintenance therapy for 1 year.

Drug: Maintainance therapy of intravesical chemotherapy-Epirubicin-

Interventions

Immediate instillation of intravesical chemotherapy-Epirubicin- DRUG

Single instillation group

Maintainance therapy of intravesical chemotherapy-Epirubicin- DRUG

Maintainance therapy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with UTUC without history of bladder tumor
• Patients with UTUC without synchronous bladder tumor

You may not qualify if:

• Patients with history of bladder tumor
• Patients with synchronous bladder tumor
• Patients with advanced stage (T4)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Ureteral Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ureteral Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Yasser M. Osman, MD

  Urology And Nephrology Center, Mansoura University, Mansoura

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 30, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

EG (1)