Localized Leiomyosarcoma Biomarker Protocol

University of Michigan Rogel Cancer Center40 enrolled

Overview

* Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS). * Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery. * 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. * Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival * Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence. * Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence. * 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Leiomyosarcoma

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum * Grade 2 or 3, or high-grade LMS * Tumor size \>5 cm in greatest dimension * Primary tumor amenable to complete resection * There is no age requirement * Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy * If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered * 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

Locations (3)

University of Michigan

Ann Arbor, Michigan, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

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

Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points

Time frame: 2 years

To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation

Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to, during, and after treatment with chemotherapy and / or radiation

Time frame: 2 years

Secondary Outcomes

To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival

The change in the presence of ctDNA from serial blood collection will be compared to the absence of sarcoma recurrence or after 2 years

Time frame: 2 years

Localized Leiomyosarcoma Biomarker Protocol

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts