Localized Leiomyosarcoma Biomarker Protocol
Study Details
Study Description
Brief Summary
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Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS).
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Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.
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Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.
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Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival
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Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.
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Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy.
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A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- To evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [2 years]
Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood sampels over multiple time points
- To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation [2 years]
Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to and after treatment with chemotherapy and / or radiation
Secondary Outcome Measures
- To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival [2 years]
The change in the presence of ctDNA from serial blood collection will be compared to the imaging characterstics in patients with relapse-free survival after 2 years
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum
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Grade 2 or 3, or high-grade LMS
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Tumor size >5 cm in greatest dimension
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Primary tumor amenable to complete resection
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There is no age requirement; however, high-grade LMS is exceeding rare in children
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Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy
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If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered
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Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H&E stained slide) from diagnostic or pre-treatment biopsy available for study research
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 2 | Mayo Clinic | Rochester | Minnesota | United States | 55901 |
| 3 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 4 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Sarcoma Alliance for Research through Collaboration
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SARC043