Surgical removal of osteosarcoma tumors before chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the functional outcomes of patients with newly diagnosed osteosarcoma of the extremity who undergo upfront surgical resection of the tumor prior to chemotherapy. Patients will have their tumors surgically removed and then receive a standard chemotherapy regimen. Throughout the first year post-surgery, patients and their surgeons will complete questionnaires to assess recovery and extremity function. The study seeks to understand if this approach leads to better functional outcomes compared to traditional treatment sequences.

Why it matters

Who can join: the full rules

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)

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Alice Lee, M.D. — Montefiore Medical Center
• Study coordinator: Rebecca Zylber, NP
• Email: rzylber@montefiore.org
• Phone: 718-741-2356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.