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Trial Title:
Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.
NCT ID:
NCT05671042
Condition:
Upper Excretory Tract Tumors
Conditions: Official terms:
Carcinoma, Transitional Cell
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Patients with Upper excretory tract tumors
Description:
Standard of care for patients with Sezary Syndrome
Arm group label:
Patients with Upper excretory tract tumors
Other name:
Standard of care
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.
Criteria for eligibility:
Study pop:
Adult patients with upper excretory tract tumors
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05671042
