RecruitingNot Applicable

Upfront Surgical Resection for Osteosarcoma

United States10 participantsStarted 2024-03-25

Plain-language summary

The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity.

Who can participate

Age range5 Years – 40 Years

SexALL

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Inclusion Criteria: * Patients must have newly diagnosed, previously untreated, localized, high-grade osteosarcoma of an extremity (verified by histopathology) with plans to undergo upfront surgical resection of the tumor followed by systemic chemotherapy. * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 (Karnofsky will be used for patients \>16 years of age and Lansky score for patients \<= 16 years of age) Exclusion Criteria: * Patients with metastatic disease at diagnosis * Initiation of systemic therapy prior to enrollment * Prior history of cancer * Prior radiation therapy * Active life-threatening infection * Pregnancy (negative pregnancy test result must be obtained for female patients of childbearing potential)

What they're measuring

Change in Health-Related Quality of Life (HRQoL) score from Historical Controls

Timeframe: approximately 1 year

Trial details

NCT IDNCT06384404

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Rebecca Zylber, NP

718-741-2356 rzylber@montefiore.org

View on ClinicalTrials.gov More Osteosarcoma trials