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NCT05671042
Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.
Conditions: Upper Excretory Tract Tumors
Sex: All
Ages: 18 Years – N/A
Enrollment: 50
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Eligibility Criteria
Inclusion Criteria:Patients over 18 years of ageMale or femaleUpper excretory tract tumorsLocalized or locally advanced stage (N0 to N1)Eligible for curative surgeryHave received neoadjuvant or primary chemotherapyNeoadjuvant chemotherapy treatment received between 2010 and 2020.Exclusion Criteria:Patient's opposition to the researchUTUC not eligible for curative surgeryLocally advanced UTUC ≥ N2 and/or metastatic.
Source: ClinicalTrials.gov (NCT05671042). StuddyBuddy aggregates publicly available trial information.