Upfront Surgical Resection for Osteosarcoma

Phase

N/A

Condition

Osteosarcoma

Treatment

Questionnaire

Clinical Study ID

NCT06384404

2023-14741

Ages 5-40
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Patients must have newly diagnosed, previously untreated, localized, high-gradeosteosarcoma of an extremity (verified by histopathology) with plans to undergoupfront surgical resection of the tumor followed by systemic chemotherapy.
Patients must have a performance status corresponding to Eastern CooperativeOncology Group (ECOG) scores of 0, 1, or 2 (Karnofsky will be used for patients >16years of age and Lansky score for patients <= 16 years of age)

Exclusion

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 ofchildbearing potential)

Study Design

Questionnaire

March 25, 2024

December 31, 2028

Study 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.

Connect with a study center

Montefiore Medical Center
Bronx, New York 10467
United States
Active - Recruiting

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