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Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.

Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05671042
Acronym
CNA TVES
Enrollment
50
Registered
2023-01-04
Start date
2023-01-31
Completion date
2024-12-31
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Excretory Tract Tumors

Brief summary

Upper tract urothelial carcinoma incidence is about 1 /100000/year. These tumors are mostly diagnosed at an invasive stage and the standard treatment is a total nephroureterectomy. In this population, indication of perioperative chemotherapy is still discussed. The benefit of platinum-based adjuvant chemotherapy was recently confirmed by the prospective trial POUT for pT2-T4 N0-3 M0 tumors with an improvement in recurrence-free survival of 51% in the chemotherapy arm. However, in this situation, use of adjuvant Cisplatin-based chemotherapy may be limited by the deterioration of renal function due to renal surgery. There are currently no recommendations on the place of neoadjuvant chemotherapy (NAC) with controversial results. Moreover, the impact on renal function of the NAC-NUT treatment sequence has so far been little studied. The aim of this study is to improve scientific knowledge about neoadjuvant chemotherapy in upper tract urothelial carcinoma eligible to a curative surgery. The investigators will evaluate the benefit of NAC on pathological response, overall survival and progression-free survival in a large multicentric cohort. In addition, the investigators will assess the impact of NAC on renal function at a distance from curative surgery will allow the evaluation of its specific toxicity.

Interventions

OTHERPatients with Upper excretory tract tumors

Standard of care for patients with Sezary Syndrome

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients over 18 years of age 2. Male or female 3. Upper excretory tract tumors 4. Localized or locally advanced stage (N0 to N1) 5. Eligible for curative surgery 6. Have received neoadjuvant or primary chemotherapy 7. Neoadjuvant chemotherapy treatment received between 2010 and 2020.

Exclusion criteria

1. Patient's opposition to the research 2. UTUC not eligible for curative surgery 3. Locally advanced UTUC ≥ N2 and/or metastatic.

Design outcomes

Primary

MeasureTime frameDescription
Pathological response rateimmediately after the end of chemotherapy treatmentPathological response rate on the surgical specimen after 4 to 6 cycles of chemotherapy (each cycle is 14 days or 21 days according to chemotherapy treatment).

Secondary

MeasureTime frameDescription
Progression free-survivalat one year
Radiological response rateimmediately after the end of chemotherapy treatmentRadiological response rate before ablation surgery after 4-6 cycles of chemotherapy.
residual renal function assessed by creatinine clearance (mL/min)at 3 months after curative surgery

Contacts

Primary ContactTiphaine LAMBERT, Dr
tiphaine.lambert@aphp.fr+33187023169
Backup ContactMatthieu RESCHE-RIGON
matthieu.resche-rigon@u-paris.fr+33142499742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026