Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-30 @ 7:59 AM
Study NCT ID:
NCT06384404
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upfront Surgical Resection for Osteosarcoma
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
Functional Outcomes in Patients Who Undergo Upfront Surgical Resection for High-Grade Osteosarcoma of the Extremity: A Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UFSR for OS
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: