RecruitingNCT06384404

Upfront Surgical Resection for Osteosarcoma

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


Sponsor

Montefiore Medical Center

Enrollment

10 participants

Start Date

Mar 25, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 40 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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)

Interventions

OTHERQuestionnaire

PROMIS questionnaire


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT06384404


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