Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety

Sarcoma Clinical Trial

— MeRCY  

Official title:

Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06216990
• Other study ID #: 2022/704
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients over 18
• with inoperable or metastatic Soft Tissue Sarcoma
• treated with Metronomic Cyclophosphamide
• in 3 cancer care institutions located in 2 French regions (Bourgogne and Franche-Comté)
• between January 2005 and December 2021

Exclusion Criteria:

• patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	Progression Rate	Proportions of patients with no reported progression at each time-point (3 and 6 months)	3 and 6 Months
Secondary	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
Secondary	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