Upfront Surgical Resection for Osteosarcoma (UFSR for OS)

March 12, 2026 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Alice Lee, M.D.
        • Sub-Investigator:
          • David Geller, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed osteosarcoma with plans to undergo an upfront surgical resection of their tumor.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Osteosarcoma
Patients with newly diagnosed osteosarcoma
Other: Questionnaire
PROMIS questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health-Related Quality of Life (HRQoL) score from Historical Controls
Time Frame: approximately 1 year

Modified age-based PROMIS measures will be used to assess HRQoL changes (PROMIS 25 Parent Proxy will be used for ages 5-7; PROMIS 25 for 8-17; PROMIS 29+2 for 18+)

PROMIS 25 (and PROMIS 25 Parent Proxy) contain six, 4-item short forms for domains: physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference; along with a pain intensity item. Scores for each domain range from 1-5 (pain intensity 0-10). Responses to individual items are coded to values and summed to generate a total raw score. Total raw scores are converted/rescaled into a standardized T-score for each participant with a mean of 50 and a standard deviation (SD) of 10. Higher PROMIS T-scores represent more of the concept being measured

PROMIS 29+2 is similar to PROMIS 25 with the exception of a social roles/activities domain in place of peer relationships, and also includes sleep disturbance and cognitive function domains. Scores are determined as described for PROMIS 25
approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival
Time Frame: Up to 2 years
The number of participants with event-free survival (EFS) will be determined. Event-free survival will be defined as the time from diagnosis until disease progression, recurrence at any site, secondary malignancy, death, or last follow-up, whichever is observed first
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Alice Lee, M.D., Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-14741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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