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NCT Number: NCT06384404

Upfront Surgical Resection for Osteosarcoma

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.

Recruiting

Interested in participating?

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Key information

Age range

5 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

Alice Lee, M.D.

PRINCIPAL_INVESTIGATOR

David Geller, M.D.

SUB_INVESTIGATOR

Rebecca Zylber

CONTACT

[email protected]

718-741-2356

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

Other

PROMIS questionnaire

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Zylber, NP

CONTACT

[email protected]

718-741-2356

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Acronym: UFSR for OS

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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