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

Completed

• Conditions: Sarcoma; Soft Tissue Sarcoma

• Registration Number: NCT06216990
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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	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.

Secondary Outcome Measures

Name	Time	Method
Control Rate	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	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.
Progression Rate	3 and 6 Months	Proportions of patients with no reported progression at each time-point (3 and 6 months)
Response Rate (RR)	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	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.
Overall Survival	From date of first administration of Metronomic Cyclophosphamide until the date of death from any cause, assessed up to 100 months	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