Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin/Gemcitabine | Active Comparator |
| |
| Fractionated Cisplatin/Gemcitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin AUC (area under curve) 4,5 at day 1 of each cycle until 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Efficacy - Rate of non progression at the end of treatment (C6D21). | Progression is defined according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria V1.1. | 5 years. |
| Phase III: Overall survival (in months). | Overall survival is defined as the time from randomization until death or last follow up news (censured data). | 9 years. |
| Phase II: Tolerance - Percentage of patients for whom at least one of the 3 defined tolerance criteria (see description) is observed. | Defined tolerance criteria :
| 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II and III: Objective response. | Objective response (ie complete or partial response) will be evaluated according to RECIST v1.1 criteria. | Phase II: 5 years ; Phase III: 9 years. |
| Phase II and III: Tolerance according to NCI toxicity scale (version 4.0). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Loic MOUREY, MD | Institut Claudius Regaud | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin | Angers | 49933 | France | |||
| Chru Besancon - Hopital Jean Minjoz |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fractionated Cisplatin | Drug | Cisplatin 35mg/m² at day 1 and day 8 of each cycle until 6 cycles. |
|
| Gemcitabine | Drug | Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles. |
|
| Phase II: 5 years ; Phase III: 9 years. |
| Phase II and III: Geriatric evaluation using questionnaires. | The geriatric assessment will be evaluate using the following questionnaires: G8 (oncodage) , ADL (activity of daily living), CIRSG (cumulating illness rating scale geriatric) , MMS (mini-mental score), IADL (instrumental activities of daily living), GDS (geriatric depression scale), MNA (mini-nutritional assessment). | Phase II: 5 years ; Phase III: 9 years. |
| Phase II and III: Quality of life using the EORTC QLQ - C30 questionnaire (European Organization for research and treatment of Cancer - Quality of life questionnaire). | Phase II: 5 years ; Phase III: 9 years. |
| Phase II and III: Pharmacokinetics - Platin concentrations | At cycles 1 and 2 day 1 - 5 mn before the end of infusion, one hour after the end of infusion, 3 hours (arm A) or 4 hours (arm B) after the end of infusion. |
| Phase II and III: Pharmacogenetics, exploration of cytidine deaminase activity and study of its genetic polymorphisms. | Prior to the initial dose on cycle 1 day 1. |
| Phase II and III: Progression free survival. | Progression free survival will be evaluated according to RECIST v1.1 criteria. | Phase II: 5 years ; phase III: 9 years. |
| Phase II and III: Overall survival. | Overall survival is defined as the time from randomization until death from all causes combined. | Phase II: 5 years ; Phase III: 9 years. |
| Phase II and III: Time to treatment failure. | Time to treatment failure is defined as the time from randomization to treatment discontinuation, whatever its cause. | Phase II: 5 years ; Phase III: 9 years. |
| Besançon |
| 25030 |
| France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| CH VERSAILLES - Hôpital André Mignot | Le Chesnay | 78157 | France |
| CHU LIMOGES - Hôpital Dupuytren | Limoges | 87042 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Ch Mont de Marsan | Mont-de-Marsan | 40024 | France |
| Institut Regional Du Cancer Montpellier | Montpellier | 34298 | France |
| Ap-Hp-Hopital Saint-Louis | Paris | 75010 | France |
| INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut de Cancerologie Lucien Neuwirth | Saint-Priest-en-Jarez | 42271 | France |
| CHU de STRASBOURG | Strasbourg | 67091 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Chru Tours | Tours | 37044 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided