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Upfront Surgery for Osteosarcoma

This observational study is looking at whether removing an osteosarcoma tumor (a type of bone cancer) from an arm or leg through surgery first, before chemotherapy, can improve how well the limb works. You might be able to join if you are between 5 and 40 years old, have newly diagnosed, untreated osteosarcoma in an arm or leg, and are planning to have surgery followed by chemotherapy. The study will measure changes in your health-related quality of life about one year after surgery, compared to people who had standard treatment. This study is currently unclear about its recruitment status and plans to enroll 10 participants.

Study design
This is a prospective, non-randomized pilot study. It will assess patient-reported functional outcomes in a small group of participants.
What's involved
You will complete questionnaires (PROMIS questionnaire) at different times during the first year after your surgery. Your surgeon will also complete a questionnaire.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for approximately one year after surgery to assess changes in your health-related quality of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06384404

Upfront Surgical Resection for Osteosarcoma

Recruiting
Not specifiedAges 5–40Observational
Montefiore Medical Center
~10 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Questionnaire

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Health-Related Quality of Life (HRQoL) score from Historical Controls
Measured over approximately 1 year

Conditions

Osteosarcoma

Explore related trials

Osteosarcoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Alice Lee, M.D. · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Rebecca Zylber, NP
[email protected]
718-741-2356
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in Health-Related Quality of Life (HRQoL) score from Historical Controlsapproximately 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