Recruiting

Surgical Resection

Sponsor:

Montefiore Medical Center

Code:

NCT06384404

Conditions

Osteosarcoma

Eligibility Criteria

Sex: All

Age: 5 - 40

Healthy Volunteers: Not accepted

Interventions

Questionnaire

Study Details

Brief 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.

Conditions

Osteosarcoma

Study ID

NCT06384404

Start date

Mar 25, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 40

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Osteosarcoma

Patients with newly diagnosed osteosarcoma

Interventions

Questionnaire

PROMIS questionnaire

Primary outcome measure

  • Change in Health-Related Quality of Life (HRQoL) score from Historical Controls [ Time Frame: approximately 1 year ]

Central Contacts and Locations

Central contacts

Rebecca Zylber, NP

718-741-2356rzylber@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Rebecca Zylber

718-741-2356rzylber@montefiore.org

Principal Investigator:

Alice Lee, M.D.

More Information

Sponsor

Montefiore Medical Center

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-03-16.