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Epithelioid Sarcoma Natural History Study

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ClinicalTrials.gov Identifier: NCT03837678
Recruitment Status : Active, not recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Analysis Group, Inc.
Information provided by (Responsible Party):
Epizyme, Inc.

Brief Summary:

This study is a multi-center, non-interventional retrospective medical records review. The study will involve identification of medical records of patients with confirmed locally advanced unresectable or metastatic ES, who initiated systemic therapy between January 1, 2000 and December 31, 2017.

Data for the chart review will be extracted retrospectively from eligible subjects' charts (electronic or paper). Information on prior surgical treatment and neoadjuvant/adjuvant therapies for ES will also be collected for ineligible subjects with a locally advanced or metastatic ES diagnosis who did not initiated systemic therapy. Data collected will be anonymized by the investigators and will not be traceable back to individual subjects by the sponsor (i.e., no protected health information [PHI] will be collected).


Condition or disease
Epithelioid Sarcoma

Detailed Description:
The sampling period will span from January 1, 2000 to December 31, 2017. As the chart abstraction dates may be different across institutions due to contracting and other logistical issues, to avoid seeing biased outcomes that may be related to this type of heterogeneity, a consistent study end date will be imposed for all patients when conducting the analysis. Information before this study end date will be analyzed and used to conduct the analysis.

Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Epithelioid Sarcoma Natural History Study
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Real-word overall response rate (rwORR) [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure ]
    Proportion of patients who have a documented radiological scan showing clinician-assessed complete response or less-than-complete response, of any duration, defined for each regimen and by line

  2. Real-world duration of response (rwDOR) [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure ]
    Duration of time between the first radiological scan showing documented tumor response (any time of response excluding SD) to first noted disease progression, or treatment discontinuation if no progression occurred. This is defined for each line of therapy and by regimen.


Secondary Outcome Measures :
  1. Time from treatment initiation to treatment discontinuation [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure ]
  2. Time from treatment initiation to treatment failure [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure ]
    Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death

  3. Real-world disease control rate (rwDCR) [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure ]
    Proportion of patients who have documented radiological scans showing clinician-assessed complete response or less-than-complete response, or stable disease lasting at least 32 weeks

  4. Overall survival (OS) [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to death ]
  5. Real-world time to tumor progression (rwTTP) [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to tumor progression ]

Other Outcome Measures:
  1. Safety Outcome: Occurrence of adverse events [ Time Frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 treatment modification or discontinuation ]
    Occurrence of adverse events resulting in treatment modification or discontinuation, or patient hospitalization, while on systemic therapy



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of Epithelioid Sarcoma (ES) patients (approximately 70 to 100) from approximately five (5) academic centers (i.e., study sites) in the US. The sampling period will span from January 1, 2000 to December 31, 2017.
Criteria

Inclusion Criteria:

  • Diagnosed with histologically confirmed, locally advanced unresectable or metastatic Epithelioid Sarcoma (ES) requiring systemic therapy during between January 1, 2000 and December 31, 2017. The date of the confirmed locally advanced unresectable or metastatic ES diagnosis is designated as the index date.
  • Patients may have a date of ES diagnosis at an earlier stage prior to 2000 and still be eligible for the study
  • Initiation of treatment with any systemic anti-cancer therapy for the treatment of their locally advanced unresectable or metastatic ES between January 1, 2000 and December 31, 2017
  • At least 10 years of age at the index date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837678


Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80045
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77054
Sponsors and Collaborators
Epizyme, Inc.
Analysis Group, Inc.

Responsible Party: Epizyme, Inc.
ClinicalTrials.gov Identifier: NCT03837678     History of Changes
Other Study ID Numbers: EZH-1001
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms