NCT06384404

Upfront Surgical Resection for Osteosarcoma

Functional Outcomes in Patients Who Undergo Upfront Surgical Resection for High-Grade Osteosarcoma of the Extremity: A Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, non-randomized pilot study will assess patient-reported functional outcomes of upfront surgical resection in patients with newly diagnosed, biopsy-proven, localized osteosarcoma of the extremity or the pelvis. Following biopsy, all patients will undergo wide excision of the tumor followed by systemic multi-agent cytotoxic chemotherapy consisting of a regimen at least equivalent to the standard of care of high dose Methotrexate, Doxorubicin, and Cisplatin (MAP). Patients and/or their parent/guardian will be administered PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires, while surgeons will be administered the Musculoskeletal Tumor Society (MSTS) questionnaire at various timepoints through the first year post-surgery.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
OTHER	Questionnaire	PROMIS questionnaire

Timeline

• Start date: 2024-03-25
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-04-25
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States