Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma
NCT ID: NCT02969083
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2018-05-28
2025-12-31
Brief Summary
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Detailed Description
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The aim of this study is to explore feasibility of UTUC treatments based in real world data in various European countries. Patients who fulfil good prognostic factors (inclusion criteria for treatment randomization) will be allocated to neo-adjuvant (Arm B) or adjuvant (Arm C) chemotherapy (receiving 3 cycles of gemcitabine/cisplatin or dose dense Methotrexate, Vinblastine, Adriamycin, and Cisplatin (MVAC). Patients who don't fulfil criteria for treatment randomization will undergo Radical nephroureterectomy (RNU) only (Arm A). Patients will be followed up for 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Radical nephro-ureterectomy (RNU)
Patients who dont fulfil inclusion criteria for chemotherapy treatment randomization (poor renal function: Glomerular Filtration Rate (GFR) \<55 ml/min or unfit for cisplatin-based chemotherapy)
RNU
Radical surgical removal by open or laparoscopic access
Gemcitabine/Cisplatin plus RNU
Patients who fulfil inclusion criteria for cisplatinum-based chemotherapy (renal function: GRF \> or = 55 ml/min) receiving 3 cycles of Gemcitabine (1000 mg/m2) + Cisplatin (70 mg/m2) every 3 weeks before surgery
RNU
Radical surgical removal by open or laparoscopic access
Gemcitabine/Cisplatin
Gemcitabine (1000 mg/m²) day 1 and 8 and Cisplatin (70 mg/m²) day 1
RNU plus Gemcitabine/Cisplatin
Patients who fulfil inclusion criteria for cisplatinum-based chemotherapy (renal function: GRF \> or = 55 ml/min) receiving 3 cycles of Gemcitabine (1000 mg/m2) + Cisplatin (70 mg/m2) every 3 weeks after surgery
RNU
Radical surgical removal by open or laparoscopic access
Gemcitabine/Cisplatin
Gemcitabine (1000 mg/m²) day 1 and 8 and Cisplatin (70 mg/m²) day 1
M-VAC protocol plus RNU
Patients who fulfil inclusion criteria for cisplatinum-based chemotherapy (renal function: GRF \> or = 55 ml/min) receiving 3 cycles of MVAC every 2 weeks (Methotrexate (30 mg /m²) , Vinblastine (3 mg /m²) , Adriamycin (30 mg /m²) , and Cisplatin (70 mg /m²) before surgery
RNU
Radical surgical removal by open or laparoscopic access
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
RNU plus M-VAC protocol
Patients who fulfil inclusion criteria for cisplatinum-based chemotherapy (renal function: GRF \> or = 55 ml/min) receiving 3 cycles of MVAC every 2 weeks (Methotrexate (30 mg /m²) , Vinblastine (3 mg /m²) , Adriamycin (30 mg /m²) , and Cisplatin (70 mg /m²) after surgery
RNU
Radical surgical removal by open or laparoscopic access
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
Interventions
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RNU
Radical surgical removal by open or laparoscopic access
Gemcitabine/Cisplatin
Gemcitabine (1000 mg/m²) day 1 and 8 and Cisplatin (70 mg/m²) day 1
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract Patients with UTUC cT2-pT4 cN0-N1 M0 (TNM classification)
* Women with negative serum pregnancy test within 14 days of first dose of study treatment and agreement to use effective contraception
* Patients without bladder cancer or with concomitant non muscle invasive bladder cancer
* Adequate organ system function defined as follows: Hematologic: Absolute neutrophil count (ANC) 1.5 X 109/L; Haemoglobin 5.6 mmol/L (9.02g/dL); Platelets 100 X 109/L; Prothrombin time (PT) or international normalized ratio (INR)b 1.2 X ULN; Activated partial thromboplastin time (aPTT)1.2 X Upper limit of normal (ULN). Hepatic: Total bilirubin 1.5 X ULN; Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) 2.5 X ULN. Renal: GRF \<or\> 55 ml/min: Electrolytes: potassium and calcium: within normal limits.
* CT scan of the chest, abdomen and pelvis and Bone scan without evidence of distant metastasis
Exclusion Criteria
* History of cardiovascular conditions within the past 6 months.
* 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
* Other active neoplasms. Patients with in situ cervical carcinoma, non-melanoma skin cancer or prostate cancer T1 Gleason \<7, Prostate specific antigen (PSA) \<10. Patients with past medical history of cancer can be included if diagnosed at least 4 years ago.
* Concomitant muscle invasive bladder cancer
* Patients who have been or still are on methotrexate treatment.
18 Years
ALL
No
Sponsors
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Centre for Human Drug Research, Netherlands
OTHER
The European Uro-Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Susanne Osanto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Centre
Locations
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Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Leiden University Medical Centre
Leiden, South Holland, Netherlands
Alrijne Ziekenhuis
Leiderdorp, South Holland, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Haukeland University Hospital
Bergen, , Norway
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitario German Trias i Pujol
Badalona, , Spain
Fundacion Puigvert
Barcelona, , Spain
Hospital Clinico de Barcelona
Barcelona, , Spain
Hospital San Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de Basurto
Bilbao, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital de Jerez
Jerez de la Frontera, , Spain
Hospital Complex Insular-Materno Infantil
Las Palmas, , Spain
Clinica Universitaria de Navarra
Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Parc Taulí
Sabadell, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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T Van der Heijden
Role: primary
S Osanto
Role: primary
C Goossens-Laan
Role: primary
R Somford
Role: primary
C Beisland
Role: primary
Dr. Molina
Role: primary
Dr. Alves
Role: primary
J Palou
Role: primary
Dr. Ribal
Role: primary
P Maroto
Role: primary
Dr. Gonzalez
Role: primary
Dr. Anton
Role: primary
Dr. Comet
Role: primary
Dr. Arrabal
Role: primary
Dr. Amores
Role: primary
Dr. Gómez de Liaño
Role: primary
Dr. Villacampa
Role: primary
Dr. Buendia
Role: primary
Dr. Burgos
Role: primary
Dr. Alvarez-Maestro
Role: primary
Dr. Lopez-Cubillana
Role: primary
Dr. Fernandez Aparicio
Role: primary
Dr. Montesino
Role: primary
Dr. Gallardo
Role: primary
Dr. Gomez Veiga
Role: primary
Dr. Campos Juanatey
Role: primary
Dr. Osman
Role: primary
Dr. Climent
Role: primary
Dr. Rioja
Role: primary
References
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Hird AE, Magee DE, Cheung DC, Sander B, Sridhar S, Nam RK, Kulkarni GS. Neoadjuvant Versus Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: A Microsimulation Model. Clin Genitourin Cancer. 2021 Apr;19(2):e135-e147. doi: 10.1016/j.clgc.2020.10.001. Epub 2020 Oct 13.
Other Identifiers
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EudraCT 2016-004017-27
Identifier Type: -
Identifier Source: org_study_id