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Osteosarcoma for Osteosarcoma (UFSR for OS Trial)

N/A
Recruiting
Led By Alice Lee, M.D.
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

UFSR for OS Trial 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.

UFSR for OS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Health-Related Quality of Life (HRQoL) score from Historical Controls
Secondary outcome measures
Event Free Survival

Side effects data

From 2019 Phase 2 trial • 60 Patients • NCT02060370
83%
Fatigue
76%
Diarrhea
61%
Platelet count decreased
58%
White blood cell decreased
54%
Mucositis oral
54%
Hand-foot syndrome
54%
Anemia
46%
Dysgeusia
44%
Nausea
41%
Rash
39%
Proteinuria
39%
Neutrophil count decreased
36%
Creatinine increased
32%
Aspartate aminotransferase increased
27%
Hypertension
25%
Hypothyroidism
24%
Vomiting
22%
Dyspepsia
20%
Hypoalbuminemia
20%
Anorexia
20%
Dyspnea
20%
Skin hypopigmentation
19%
Alanine aminotransferase increased
17%
Watering eyes
15%
Edema
14%
Weight loss
14%
Oral dysesthesia
14%
Epistaxis
14%
Pruritus
12%
Hyperglycemia
12%
Gastroesophageal reflux disease
12%
Lymphocyte count decreased
12%
Hypocalcemia
10%
Alkaline phosphatase increased
10%
Blood bilirubin increased
10%
Constipation
10%
Dysesthesia
10%
Headache
8%
Hyponatremia
8%
TSH increased
7%
Dry skin
7%
Anal mucositis
7%
Hypomagnesemia
7%
Hair hypopigmentation
7%
Myalgia
7%
Dry mouth
7%
Non-cardiac chest pain
7%
Paresthesia
5%
Alopecia
5%
Bloating
5%
Thromboembolic event
5%
CD4 lymphocytes decreased
5%
Hyperkalemia
5%
Thrombotic thrombocytopenic purpura
5%
Abdominal pain
5%
Hemoglobinuria
2%
Dehydration
2%
Vascular access complication
2%
Hypophosphatemia
2%
Gout
2%
Pancreatic insufficiency
2%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sunitinib

UFSR for OS Trial Design

1Treatment groups
Experimental Treatment
Group I: OsteosarcomaExperimental Treatment1 Intervention
Patients with newly diagnosed osteosarcoma

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
444 Previous Clinical Trials
582,550 Total Patients Enrolled
Alice Lee, M.D.Principal InvestigatorMontefiore Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Upfront Surgical Resection for Osteosarcoma
2024. "Upfront Surgical Resection for Osteosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06384404.
All > New York City > Philadelphia
~7 spots leftby Dec 2027
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