Upper Tract Urothelial CarcinomaPhase 2URANUSNCT02969083
Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma
A Phase 2 study testing RNU, Gemcitabine/Cisplatin and M-VAC Protocol in people with Upper Tract Urothelial Carcinoma, run by The European Uro-Oncology Group at 29 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- RNU, Gemcitabine/Cisplatin and M-VAC Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 28 May 2018to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
Spain24 sites, 24 recruiting
- Not yet recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña
Dr. Molina
- Recruiting
Hospital Universitario German Trias i Pujol
Badalona
Dr. Alves
- Recruiting
Fundacion Puigvert
Barcelona
J Palou
- Not yet recruiting
Hospital Clinico de Barcelona
Barcelona
Dr. Ribal
- Recruiting
Hospital San Pau
Barcelona
P Maroto
- Not yet recruiting
Hospital Universitario Vall d'Hebron
Barcelona
Dr. Gonzalez
- Not yet recruiting
Hospital Universitario de Basurto
Bilbao
Dr. Anton
- Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona
Dr. Comet
- Recruiting
Hospital Universitario Clínico San Cecilio
Granada
Dr. Arrabal
- Not yet recruiting
Hospital de Jerez
Jerez de la Frontera
Dr. Amores
- Not yet recruiting
Hospital Complex Insular-Materno Infantil
Las Palmas
Dr. Gómez de Liaño
- Recruiting
Clinica Universitaria de Navarra
Madrid
Dr. Villacampa
- Not yet recruiting
Fundacion Jimenez Diaz
Madrid
Dr. Buendia
- Recruiting
Hospital ramón y Cajal
Madrid
Dr. Burgos
- Recruiting
Hospital Universitario La Paz
Madrid
Dr. Alvarez-Maestro
- Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia
Dr. Lopez-Cubillana
- Not yet recruiting
Hospital General Universitario Morales Meseguer
Murcia
Dr. Fernandez Aparicio
- Recruiting
Complejo Hospitalario de Navarra
Pamplona
Dr. Montesino
- Recruiting
Hospital Parc Taulí
Sabadell
Dr. Gallardo
- Recruiting
Hospital Universitario de Salamanca
Salamanca
Dr. Gomez Veiga
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander
Dr. Campos Juanatey
- Recruiting
Hospital Virgen del Rocio
Seville
Dr. Osman
- Not yet recruiting
Fundacion Instituto Valenciano de Oncologia
Valencia
Dr. Climent
- Not yet recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Dr. Rioja
Netherlands4 sites, 4 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, South Holland
S Osanto
- Recruiting
Alrijne Ziekenhuis
Leiderdorp, South Holland
C Goossens-Laan
- Recruiting
Radboud University Medical Centre
Nijmegen, Gelderland
T Van der Heijden
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
R Somford
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen
C Beisland
About this study
Official title: Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma: A Feasibility Phase II Randomized Clinical Trial ("URANUS")"
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.
Read the detailed description
There are no definitive treatment recommendations for patients diagnosed with UTUC. Radical nephroureterectomy (RNU) has been considered the gold standard treatment for UTUC. However due to the high recurrence rates reported, patients are often offered perioperative chemotherapy provided that they have a good renal function and performance status. With regard to the choice of chemotherapy treatment, there are also no clear recommendations since there are no data from randomized studies. If perioperative chemotherapy is considered in daily practice, gemcitabine/cisplatin regimen is often chosen and occasionally dd-MVAC.
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
- Upper Tract Urothelial Carcinoma
- Being tested
- RNU, Gemcitabine/Cisplatin, M-VAC Protocol
- Keywords
- UTUC, Upper Tract Urothelial Carcinoma, Neoadjuvant chemotherapy, Adjuvant chemotherapy, Radical nephroureterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNUProcedure or surgery
Also called Radical nephro-ureterectomy
Radical surgical removal by open or laparoscopic access
Gemcitabine/CisplatinDrug
Also called Gemcitabine plus Cisplatin
Gemcitabine (1000 mg/m²) day 1 and 8 and Cisplatin (70 mg/m²) day 1
M-VAC ProtocolDrug
Also called DD MVAC
Methotrexate (30 mg /m²) and Vinblastine 3 (mg /m²) day 1; Adriamycin 30 mg /m² and Cisplatin 70 mg /m² in day2
| Study group | Role | What they receive |
|---|---|---|
| Radical nephro-ureterectomy (RNU) | Other | 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) Receives: Procedure: RNU |
| Gemcitabine/Cisplatin plus RNU | Other | 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 Receives: Procedure: RNU; Drug: Gemcitabine/Cisplatin |
| RNU plus Gemcitabine/Cisplatin | Other | 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 Receives: Procedure: RNU; Drug: Gemcitabine/Cisplatin |
| M-VAC protocol plus RNU | Other | 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 Receives: Procedure: RNU; Drug: M-VAC Protocol |
| RNU plus M-VAC protocol | Other | 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 Receives: Procedure: RNU; Drug: M-VAC Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy
Percentage of patients randomised to adjuvant or neo-adjuvant treatment
Measured: 6 months
Secondary outcomes (3)
Disease Free Survival (DFS)
time from randomisation to local recurrence or distant metastasis
Measured: 1-2 years
Overall Survival (OS)
time from randomisation to death for any cause different from urothelial carcinoma
Measured: 1-2 years
Cancer-Specific Survival (CSS)
time from randomisation to death from urothelial carcinoma
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start28 May 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The European Uro-Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Human Drug Research, Netherlands
- Responsible party
- Sponsor
- Investigators
- Susanne Osanto, MD, PhD, Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969083
- Sponsor's protocol ID
- EudraCT 2016-004017-27
- Acronym
- URANUS
- Status last verified
- Mar 2023
- First submitted
- 11 Nov 2016
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results obtained in this study will be disseminated and published
Publications
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.
PubMed 33168398
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma: A Feasibility Phase II Randomized Clinical Trial ("URANUS")"
- ClinicalTrials.gov ID
- NCT02969083
- Acronym / sponsor ID
- URANUS / EudraCT 2016-004017-27
- Conditions
- Upper Tract Urothelial Carcinoma
- Keywords
- UTUC, Upper Tract Urothelial Carcinoma, Neoadjuvant chemotherapy, Adjuvant chemotherapy, Radical nephroureterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The European Uro-Oncology GroupUniversity, hospital or other
- Collaborators
- Centre for Human Drug Research, Netherlands
- Study start
- 28 May 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are no definitive treatment recommendations for patients diagnosed with UTUC. Radical nephroureterectomy (RNU) has been considered the gold standard treatment for UTUC. However due to the high recurrence rates reported, patients are often offered perioperative chemotherapy provided that they have a good renal function and performance status. With regard to the choice of chemotherapy treatment, there are also no clear recommendations since there are no data from randomized studies. If perioperative chemotherapy is considered in daily practice, gemcitabine/cisplatin regimen is often chosen and occasionally dd-MVAC.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Radical nephro-ureterectomy (RNU) | Other | Procedure: RNUPatients 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) |
| Gemcitabine/Cisplatin plus RNU | Other | Procedure: RNU, Drug: Gemcitabine/CisplatinPatients 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 plus Gemcitabine/Cisplatin | Other | Procedure: RNU, Drug: Gemcitabine/CisplatinPatients 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 |
| M-VAC protocol plus RNU | Other | Procedure: RNU, Drug: M-VAC ProtocolPatients 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 plus M-VAC protocol | Other | Procedure: RNU, Drug: M-VAC ProtocolPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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-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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNUAlso: Radical nephro-ureterectomyRadical surgical removal by open or laparoscopic access | Procedure or surgery | Gemcitabine/Cisplatin plus RNU, M-VAC protocol plus RNU, RNU plus Gemcitabine/Cisplatin, RNU plus M-VAC protocol, Radical nephro-ureterectomy (RNU) |
| Gemcitabine/CisplatinAlso: Gemcitabine plus CisplatinGemcitabine (1000 mg/m²) day 1 and 8 and Cisplatin (70 mg/m²) day 1 | Drug | Gemcitabine/Cisplatin plus RNU, RNU plus Gemcitabine/Cisplatin |
| M-VAC ProtocolAlso: DD MVACMethotrexate (30 mg /m²) and Vinblastine 3 (mg /m²) day 1; Adriamycin 30 mg /m² and Cisplatin 70 mg /m² in day2 | Drug | M-VAC protocol plus RNU, RNU plus M-VAC protocol |
Primary outcome
Proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy
Time frame: 6 months
Percentage of patients randomised to adjuvant or neo-adjuvant treatment
3 secondary outcomes
Disease Free Survival (DFS)
Time frame: 1-2 years
Overall Survival (OS)
Time frame: 1-2 years
Cancer-Specific Survival (CSS)
Time frame: 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 33168398Hird 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.
- Individual participant dataSharing planned: No. The results obtained in this study will be disseminated and published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Osanto, MD, PhD principal investigator
Leiden University Medical Centre
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RNU, Gemcitabine/Cisplatin and M-VAC Protocol in people with Upper Tract Urothelial Carcinoma, run by The European Uro-Oncology Group at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Alvarez, MSc, PhD (+31(0)715264109, m.c.alvarez@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.