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

NCT06216990 | Completed

• 1 other identifier: 2022/704
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcoma; Soft Tissue Sarcoma

Keywords

Cyclophosphamide; Administration, Metronomic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival

  From date of first administration of Metronomic Cyclophosphamide until the date of death from any cause, assessed up to 100 months

• Progression Rate

  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

• 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

Other Outcomes (1)

• Imputable Toxicity Occurence

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 with inoperable or metastatic STS, treated with MCP in non curative settings.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Clément BOLOGNINI

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 22, 2024
• Study Start: January 1, 2005
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: January 22, 2024

Record last verified: 2023-12