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

NCT ID: NCT05671042

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

Upper Excretory Tract Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with Upper excretory tract tumors

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

Patients with Upper excretory tract tumors

Intervention Type: OTHER

Standard of care for patients with Sezary Syndrome

Interventions

Patients with Upper excretory tract tumors

Standard of care for patients with Sezary Syndrome

Intervention Type: OTHER

Other Intervention Names

Standard of care

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tiphaine LAMBERT, Dr

Role: CONTACT

tiphaine.lambert@aphp.fr

+33187023169

Matthieu RESCHE-RIGON

Role: CONTACT

matthieu.resche-rigon@u-paris.fr

+33142499742

Other Identifiers

APHP220678

Identifier Type: -

Identifier Source: org_study_id