Clinical trial · Interventional
A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.
Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.
- 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)
This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included. Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm: * Fractionated Cisplatin + Gemcitabine. * Carboplatin + Gemcitabine. The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population. The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Urothelial Cancer | — | UNRESOLVED | — |
| Metastatic Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Fractionated Cisplatin | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Carboplatin/Gemcitabine
- interventionNames
- Drug: Carboplatin
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Fractionated Cisplatin/Gemcitabine
- interventionNames
- Drug: Fractionated Cisplatin
- Drug: Gemcitabine
Primary outcomes (3)
- measure
- Phase II: Efficacy - Rate of non progression at the end of treatment (C6D21).
- timeFrame
- 5 years.
- description
- Progression is defined according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria V1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. . Age \< or = 18 years, patients aged 75 years or more will benefit from a geriatric assessment. 2. . Advanced or metastatic urothelial cancer confirmed histologically or cytologically. 3. . Patients liable to receive a first -line chemotherapy for advanced or metastatic urothelial carcinoma. 4. . Measurable disease according to RECIST criteria V1.1. 5. . Patients who received neoadjuvant or adjuvant chemotherapy based on platinum salt must have completed treatment at least 6 months before entering the study. 6. . Performance status \< or = 2. 7. . Life expectancy \> 3 months. 8. . Patients with creatinine clearance between 40 and 60 ml / min ( according to Cockcroft and Gault ). 9. . Patients having no contra-indication to overhydration. 10. . Satisfactory hematological tests: Neutrophils \> 1.5 G / l Platelets \> 150 G / l , hemoglobin ≥ 10 g / dl. 11. . Satisfactory liver function tests: total bilirubin \< 1.5 x ULN (upper limit of normal), AST (aspartate aminotransferase) and ALT (alanine aminotransferase)\<or = 2.5 x ULN (or 5 x ULN if liver metastases). 12. . In case of prior radiotherapy, a minimum of 14 days must relapse between the end of radiotherapy and study entry. 13. . For women of childbearing age , use an effective contraceptive method to study entry and for the duration of the study and 6 months after the last dose of study treatment ; For sexually active fertile men having a partner of childbearing age using effective contraception for the duration of the study and 6 months after the last dose of study treatment. 14. . Patient affiliated to a social security system in France. 15. . Patient signed informed consent before inclusion in the study and before any specific procedure for the study. Exclusion Criteria: 1. . Any concomitant or previous malignancy within 5 years prior to the study ( with the exception of basal cell or squamous cell carcinoma in situ). 2. . Pregnant or lactating women. 3. . Patients with brain metastases or meningeal or symptoms suggestive of such secondary locations. 4. . Bisphosphonate or Denosumab treatment initiated within 28 days prior to randomization into the study or patient who have started such treatment during the study ( a bisphosphonate or denosumab treatment initiated within a period longer than 28 days before randomization may be continued without change during the study ). 5. . Other concomitant cancer (radiation therapy, radiopharmaceutical agent chemotherapy). 6. . Patients with uncontrolled infection. 7. . Patients with peripheral neuropathy grade\> 1, whatever the origin or patients with hearing loss. 8. . Patient with unstable disease (eg: unstable diabetes, poorly controlled hypertension , congestive heart failure or myocardial infarction within 3 months prior to study entry). 9. . Known hypersensitivity to study drugs. 10. . Treatment with any other investigational drug within 30 days before inclusion. 11. . Any psychological condition , familial, sociological or geographical not to comply with medical monitoring and / or procedures in the study protocol. 12. . Patient protected by law.
References
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