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

Not yet recruiting

• Conditions: Upper Excretory Tract Tumors
• Interventions: Other: Patients with Upper excretory tract tumors

• Registration Number: NCT05671042
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-31
• Status Verified: 2023-01
• Study Start: 2023-01
• Study First Submitted QC: 2023-01-03
• Last Update Submitted: 2023-01-03
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pathological response rate	immediately after the end of chemotherapy treatment	Pathological 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 Outcome Measures

Name	Time	Method
Progression free-survival	at 4 years
Radiological response rate	immediately after the end of chemotherapy treatment	Radiological 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