EDEN : Prospective therapeutic de-escalation and miRNA-M371 biomarker evaluation Phase II study for stage IIa/IIb < 3 cm seminomas

Conditions

Stage IIa/IIb < 3 cm seminoma

Brief summary

the progression-free rate at 36 months (PFR-36m) defined as the proportion of patients with a complete response (CR), a partial response (PR) or a stable disease (SD) at 36 months according to RECIST v1.1. Prevalence of events (relapse or death) is expected to be low

Detailed description

- Association between serum level of miRNA-M371 (MiRNA-M371 expression rate measured before the introduction of chemotherapy, before the second cycle of chemotherapy (EP or carboplatin) or before the beginning of radiotherapy and at the end of treatment) and response to treatment (according to RECIST v1.1), - Correlation between serum level of miRNA-M371 and FDG-PET results (complete metabolic response),, - OS, defined as the time from the date of inclusion to the date of death from any cause. Any patient whose death is not known at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive, - QoL, assessed using the EORTC QLQ-C30 (baseline, at the end of treatment visit)., - Safety profile, determined using the NCI-CTC AE grading scale version 5. Adverse events will be described by their intensity and severity.

Related papers

No related papers found yet.

Interventions

DRUGCARBOPLATIN

DRUGCisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGETOPOSIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
the progression-free rate at 36 months (PFR-36m) defined as the proportion of patients with a complete response (CR), a partial response (PR) or a stable disease (SD) at 36 months according to RECIST v1.1. Prevalence of events (relapse or death) is expected to be low	—

Secondary

Measure	Time frame
- Association between serum level of miRNA-M371 (MiRNA-M371 expression rate measured before the introduction of chemotherapy, before the second cycle of chemotherapy (EP or carboplatin) or before the beginning of radiotherapy and at the end of treatment) and response to treatment (according to RECIST v1.1), - Correlation between serum level of miRNA-M371 and FDG-PET results (complete metabolic response),, - OS, defined as the time from the date of inclusion to the date of death from any cause. Any patient whose death is not known at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive, - QoL, assessed using the EORTC QLQ-C30 (baseline, at the end of treatment visit)., - Safety profile, determined using the NCI-CTC AE grading scale version 5. Adverse events will be described by their intensity and severity.	—

Measure

Time frame

- Association between serum level of miRNA-M371 (MiRNA-M371 expression rate measured before the introduction of chemotherapy, before the second cycle of chemotherapy (EP or carboplatin) or before the beginning of radiotherapy and at the end of treatment) and response to treatment (according to RECIST v1.1), - Correlation between serum level of miRNA-M371 and FDG-PET results (complete metabolic response),, - OS, defined as the time from the date of inclusion to the date of death from any cause. Any patient whose death is not known at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive, - QoL, assessed using the EORTC QLQ-C30 (baseline, at the end of treatment visit)., - Safety profile, determined using the NCI-CTC AE grading scale version 5. Adverse events will be described by their intensity and severity.

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Countries

France

Outcome results

None listed