Clinical trial · Observational
Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Excretory Tract Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients with Upper excretory tract tumors | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with Upper excretory tract tumors
- description
- Adult patient with Upper excretory tract tumors Neoadjuvant chemotherapy treatment received between 2010 and 2020.
- interventionNames
- Other: Patients with Upper excretory tract tumors
Primary outcomes (1)
- measure
- Pathological response rate
- timeFrame
- immediately after the end of chemotherapy treatment
- description
- 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 outcomes (6)
- measure
- Progression free-survival
- timeFrame
- at one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available