Surgical removal of osteosarcoma tumors before chemotherapy
Functional Outcomes in Patients Who Undergo Upfront Surgical Resection for High-Grade Osteosarcoma of the Extremity: A Pilot Study
This study is testing if removing osteosarcoma tumors from the arms or legs before starting chemotherapy helps patients recover better and improves how well they can use their limbs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 5 Years to 40 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, Methotrexate, Doxorubicin |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06384404 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed, localized, high-grade osteosarcoma of an extremity who are planning to undergo surgical resection followed by chemotherapy.
Not a fit: Patients with metastatic disease, prior cancer history, or those who have started systemic therapy before enrollment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and functional outcomes for patients with osteosarcoma.
How similar studies have performed: While this approach is being explored in this pilot study, similar studies have shown varying results, indicating that this methodology is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.