Feasibility study of Neo-adjuvant (before surgery) versus Adjuvant (after surgery) chemotherapy in Upper Tract Urothelial Carcinoma

Phase 2

Not yet recruiting

• Conditions: Upper Tract Urothelial Carcinoma. Upper urinary tract transitional cell carcinoma

• Registration Number: 2024-514991-41-01
• Lead Sponsor: European Uro-Oncology Group Stichting

Brief Summary

To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based chemotherapy treatment.

To assess the proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy.

To assess the administered versus planned dose of chemotherapy in patients randomized to neo- or adjuvant chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-17
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

written informed consent • Age ≥ 18 years. • Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract •Patients with UTUC cT2-cT4 cN0-N1 M0 (TNM classification) •Women of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception •Patients without bladder cancer or with concomitant non muscle invasive bladder cancer •Adequate organ system function defined by Hematological results •CT scan of the chest, abdomen and pelvis and bone scan without evidence of distant metastasis

Exclusion Criteria

•Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or predominant small cell carcinoma. •History of cardiovascular conditions within the past 6 months. •Incidentally found asymptomatic pulmonary embolism (PE) or recent deep vein thrombosis (DVT) is not an exclusion criteria but requires anticoagulation treatment. •Any major contraindication to a surgical procedure. •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. •Active infection contraindicating chemotherapy (under investigator criteria). •Other active neoplasms •Concomitant muscle invasive bladder cancer. •Patients who have received prior cisplatin based treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy		Proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy

Secondary Outcome Measures

Name	Time	Method
1- 2 and 3-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS)		1- 2 and 3-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS)

Trial Locations

Locations (40)

Hospital Universitario De Salamanca; 🇪🇸 Salamanca, Spain

Hospital Son Llatzer; 🇪🇸 Palma, Spain

Hospital Universitario Marques De Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario Clinico San Cecilio; 🇪🇸 Granada, Spain

Hospital Universitario Basurto; 🇪🇸 Bilbao, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

El Hospital Universitario De Gran Canaria Dr. Negrin; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital General Universitario Santa Lucia; 🇪🇸 Cartagena, Spain

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca; 🇪🇸 Barcelona, Spain

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Hospital Universitario De Salamanca

🇪🇸Salamanca, Spain

Manuel Herrero

Site contact

923291100

mherrerop@saludcastillayleon.es