Actively Recruiting
Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2023-05-30
50
Participants Needed
9
Research Sites
261 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Nīmes
Lead Sponsor
P
Pitié-Salpêtrière Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively. The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.
CONDITIONS
Official Title
Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has been correctly informed and has given signed consent.
- Patient is covered by a health insurance scheme.
- Patients aged over 70 must have a G8 score of at least 14.
- Patient's body weight must be over 30kg.
- Patient has high-grade urothelial carcinoma of the renal pelvis or ureter confirmed by biopsy or urine cytology.
- Presence of divergent histologies may be included if over 90% urothelial component is present.
- Presence of either high-grade disease on tumor biopsy or high-grade disease on urine cytology with imaging evidence of invasive disease and negative cystoscopy.
- In absence of histological evidence, multidisciplinary consultation opinion will guide inclusion.
- No prior systemic therapies.
- ECOG performance status 0 to 1.
- No distant metastasis or limited lymph node involvement on CT scan.
- Required initial laboratory values including neutrophils, platelets, hemoglobin, liver enzymes, alkaline phosphatase, INR, and aPTT within specified limits.
- For Cohort 1: Estimated glomerular filtration rate over 60 ml/min/1.73m².
- For Cohort 2: Estimated glomerular filtration rate between 40 and 60 ml/min/1.73m².
- Patients with reproductive potential must use effective contraception during the trial.
- Life expectancy of at least 12 weeks.
You will not qualify if you...
- Participation in another interventional trial or within an exclusion period from a previous study.
- Under judicial protection or adult guardianship.
- Refusal or inability to give informed consent.
- Pregnant or breastfeeding.
- Concurrent diagnosis of muscle invasive or high-grade non-muscle invasive urothelial carcinoma of the bladder.
- Severe heart disease (NYHA class III or IV).
- Serious medical or psychiatric illness including active infection.
- Use of other investigational drugs.
- Immunodeficiency or recent immunosuppressive therapy.
- Additional malignancy within 5 years except some skin cancers and treated cervical cancer.
- Active autoimmune disease requiring systemic treatment within 3 months or severe autoimmune history, with some exceptions.
- History of HIV infection.
- Active infections including tuberculosis, hepatitis B or C.
- Recent live vaccination within 30 days before treatment.
- Major surgery within 28 days before treatment, except certain palliative surgeries.
- History of organ transplantation.
- Uncontrolled illness or conditions limiting study compliance or increasing risk.
- Female patients pregnant or breastfeeding or patients unwilling to use effective birth control during and after treatment.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Hôpital Bichat-Claude Bernard
Paris, Paris Cx 20, France, 75018
Actively Recruiting
2
Institut Paoli Calmette
Marseille, France, 13009
Actively Recruiting
3
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
4
Hôpital Pitié Salpétrière
Paris, France, 75013 Paris
Actively Recruiting
5
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
6
Centre hospitalier Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
7
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
8
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
9
Iuct Oncopole
Toulouse, France, 31059
Actively Recruiting
Research Team
N
Nadine HOUEDE, Pr.
CONTACT
A
Annissa MEZGARI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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