SarcomaMeRCYNCT06216990
Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety
An observational study of Sarcoma and Soft Tissue Sarcoma, run by Centre Hospitalier Universitaire de Besancon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue Sarcoma
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 with inoperable or metastatic STS, treated with MCP in non curative settings.
Who may be able to join
- 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
Who cannot join
- patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors
About this study
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
- Medical subject headings
- Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: From date of first administration of Metronomic Cyclophosphamide until the date of death from any cause, assessed up to 100 months
Progression Rate
Proportions of patients with no reported progression at each time-point (3 and 6 months)
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jan 2005
- Primary completion31 Dec 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clément BOLOGNINI, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216990
- Sponsor's protocol ID
- 2022/704
- Acronym
- MeRCY
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Clinical data cannot be made publicly available because of privacy issues. However, additional results and aggregated findings are available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT06216990
- Acronym / sponsor ID
- MeRCY / 2022/704
- Conditions
- Sarcoma, Soft Tissue Sarcoma
- Keywords
- Cyclophosphamide, Administration, Metronomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 with inoperable or metastatic STS, treated with MCP in non curative settings.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 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
Progression Rate
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided. Clinical data cannot be made publicly available because of privacy issues. However, additional results and aggregated findings are available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clément BOLOGNINI principal investigator
CHU Besançon
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Soft Tissue Sarcoma, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.