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

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Progression-Free Survival (PFS)

Time frame: 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 outcomes

Overall Survival

Time frame: 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
Progression Rate

Time frame: 3 and 6 Months

Proportions of patients with no reported progression at each time-point (3 and 6 months)
Response Rate (RR)

Time frame: 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.
Control Rate

Time frame: 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.

Other outcomes

Imputable Toxicity Occurence

Time frame: 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

Occurence, Nature and Grades according to CTCAE 5.0 of clinicians-reported adverse events imputable to metronomic cyclophosphamide

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: MeRCY

Important dates

Study start: 2005
Primary completion: 2021
Study completion: 2022
First posted: Jan 22, 2024
Registry last updated: Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed