Localized Leiomyosarcoma Biomarker Protocol
Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Jun 11, 2021
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a type of cancer called localized leiomyosarcoma (LMS), which is a rare and aggressive tumor found in soft tissues. The goal of the trial is to better understand how certain markers in the blood and tumor tissue can help predict how well patients respond to chemotherapy. Researchers will collect blood samples before, during, and after treatment to look for circulating tumor DNA (ctDNA), which might indicate how the tumor is responding to the chemotherapy. They will also analyze tumor tissue and images from scans taken during treatment. By following patients for two years after starting the study, the team hopes to find a reliable way to assess the effectiveness of chemotherapy and improve treatment plans for patients at risk of their cancer returning.
To be eligible for this trial, patients must have a specific type of localized LMS that is at least 5 cm in size and can be surgically removed. There are no age restrictions, and both men and women can participate. Participants will receive a combination of chemotherapy drugs called doxorubicin and ifosfamide before surgery. If they have had radiation treatment, it must occur after the chemotherapy. This study is currently recruiting participants and aims to provide valuable insights that could enhance cancer care for patients with this challenging condition.
Gender
ALL
Eligibility criteria
- 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
About University Of Michigan Rogel Cancer Center
The University of Michigan Rogel Cancer Center is a leading academic research institution dedicated to advancing cancer treatment and prevention through innovative clinical trials. As a National Cancer Institute-designated Comprehensive Cancer Center, it combines cutting-edge research, state-of-the-art facilities, and a multidisciplinary team of experts to deliver personalized care and foster groundbreaking discoveries. The center's commitment to improving patient outcomes is reflected in its robust portfolio of clinical trials, which explore novel therapies and enhance understanding of cancer biology. Through collaboration with patients, researchers, and healthcare professionals, the Rogel Cancer Center aims to translate scientific insights into transformative therapies, ultimately contributing to the global fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Ann Arbor, Michigan, United States
New York, New York, United States
Nashville, Tennessee, United States
Patients applied
Trial Officials
Scott Schuetze
Principal Investigator
University of Michigan Rogal Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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