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
Not provided
Metronomic Cyclophosphamide's use in monotherapy as a palliative treatment against non-resectable and metastatic Soft Tissue Sarcomas relies on small retrospective cohorts' data.
Current litterature needs external validation of its efficacy and safety profile in these settings of usually frail patients.
The investigators assessed further data and aimed to identify predictive factors of metronomic cyclophosphamide impact in metastatic Soft Tissue Sarcomas.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-Free Survival is defined as the period from the first day of Metronomic Cyclophosphamide administration until the day of progression or death from any cause Assessment period was from the day of the first day of MCP administration until the first observation of progression or death from any cause. Disease progression is defined according to RECIST Ver. 1.1. | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival is defined as the period from the first day of Metronomic Cyclophosphamide administration until the day of death from any cause Assessment period was from the day of the first day of Metronomic Cyclophosphamide administration until the first observation of death | From date of first administration of Metronomic Cyclophosphamide until the date of death from any cause, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Imputable Toxicity Occurence | Occurence, Nature and Grades according to CTCAE 5.0 of clinicians-reported adverse events imputable to metronomic cyclophosphamide | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients over 18 with inoperable or metastatic STS, treated with MCP in non curative settings.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clément BOLOGNINI | CHU Besançon | Principal Investigator |
Not provided
Clinical data cannot be made publicly available because of privacy issues. However, additional results and aggregated findings are available on reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Progression Rate | Proportions of patients with no reported progression at each time-point (3 and 6 months) | 3 and 6 Months |
| Response Rate (RR) | Proportion of Complete Response and Partial Response among the study population from the first day of Metronomic Cyclophosphamide administration until the day of progression or death from any cause. | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Control Rate | Included Complete Response, Partial Response, and Stable Disease according to RECIST for at least 12 weeks from the first day of Metronomic Cyclophosphamide administration until the day of progression or death from any cause. | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |