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Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma

NCT02969083 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-12-18

No results posted yet for this study

Summary

The aim of this study is to explore feasibility of Upper Tract Urothelial Carcinoma (UTUC) treatments based in real world data in various European countries. The study will allow to gain insight in the true proportion of patients that fit to receive complete cisplatin-based neo-adjuvant or adjuvant chemotherapy, and the proportion and clinical outcome of patients with poor prognostic factors (PS and renal function) who receive only standard treatment (Radical nephroureterectomy (RNU)). This comparison will be made using a uniform diagnostic and treatment protocol.

Conditions

  • Upper Tract Urothelial Carcinoma

Interventions

PROCEDURE

RNU

Radical surgical removal by open or laparoscopic access

DRUG

Gemcitabine/Cisplatin

Gemcitabine (1000 mg/m²) day 1 and 8 and Cisplatin (70 mg/m²) day 1

DRUG

M-VAC Protocol

Methotrexate (30 mg /m²) and Vinblastine 3 (mg /m²) day 1; Adriamycin 30 mg /m² and Cisplatin 70 mg /m² in day2

Sponsors & Collaborators

  • Centre for Human Drug Research, Netherlands

    collaborator OTHER

  • The European Uro-Oncology Group

    lead OTHER

Principal Investigators

  • Susanne Osanto, MD, PhD · Leiden University Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Netherlands
  • Norway
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969083 on ClinicalTrials.gov