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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02240017
Other study ID # 13 URO 02
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 21, 2015
Est. completion date July 15, 2019

Study information

Verified date August 2019
Source Institut Claudius Regaud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Intervention

Drug:
Carboplatin
Carboplatin AUC (area under curve) 4,5 at day 1 of each cycle until 6 cycles.
Fractionated Cisplatin
Cisplatin 35mg/m² at day 1 and day 8 of each cycle until 6 cycles.
Gemcitabine
Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles.

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Sponsors (1)

Lead Sponsor Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary Phase II: Tolerance - Percentage of patients for whom at least one of the 3 defined tolerance criteria (see description) is observed. Defined tolerance criteria :
Postponement of chemotherapy > or = 2 weeks.
Alteration of renal function.
Need to decrease twice Gemcitabine dose on day 1 for : NCI CTC (National Cancer Institut Common Toxicity Criteria) grade III or IV non-hematologic toxicity, hematologic toxicity.
5 years.
Secondary 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.
Secondary Phase II and III: Tolerance according to NCI toxicity scale (version 4.0). Phase II: 5 years ; Phase III: 9 years.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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