Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study. (CNA TVES)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Upper Excretory Tract Tumors

Treatments: Other: Patients with Upper excretory tract tumors

Study type: Observational

Funder types: Other

Identifiers

NCT05671042

APHP220678

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Patients with Upper excretory tract tumors

Description:

Adult patient with Upper excretory tract tumors Neoadjuvant chemotherapy treatment received between 2010 and 2020.

Treatment:

Other: Patients with Upper excretory tract tumors