10 Participants Needed

Surgical Resection for Osteosarcoma

(UFSR for OS Trial)

Recruiting at 1 trial location
RZ
Overseen ByRebecca Zylber, NP
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Montefiore Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating osteosarcoma, a type of bone cancer, in its early stages. Researchers aim to determine if removing the tumor through surgery before starting chemotherapy can improve limb function during recovery. They will gather feedback from patients and surgeons through questionnaires to understand the impact on recovery. This trial seeks individuals recently diagnosed with high-grade osteosarcoma in an arm or leg who have not yet started any cancer treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in osteosarcoma care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that upfront surgical resection is safe for patients with osteosarcoma?

Research has shown that surgery to remove the tumor first in osteosarcoma patients may be safe. Studies comparing different treatment timings found that patients who underwent surgery first had a 74% survival rate over five years, slightly higher than those who received chemotherapy first. This suggests that upfront surgery is generally well-tolerated, meaning it doesn't cause unexpected problems for most people. The focus on early tumor removal might improve recovery and limb function. While the study doesn't provide detailed safety data, existing evidence indicates that surgery is a common and manageable approach for treating osteosarcoma.12345

Why are researchers excited about this trial?

Unlike the standard treatments for osteosarcoma, which typically involve chemotherapy to shrink the tumor before surgical removal, the approach under study involves upfront surgical resection. Researchers are excited about this because directly removing the tumor right away could potentially reduce the risk of cancer spreading and might improve recovery times. Additionally, this method could help identify patients who may not need intensive chemotherapy, sparing them from its side effects. Overall, this approach could lead to more personalized and potentially more effective treatment plans for patients with osteosarcoma.

What evidence suggests that upfront surgical resection is effective for osteosarcoma?

Research has shown that removing the tumor through surgery before starting chemotherapy might improve survival rates for osteosarcoma patients. One study found that patients who had surgery first had a 74% chance of living for five years, compared to 67% for those who started with chemotherapy. This approach may also help patients regain more movement and use of their limbs. Early findings suggest that removing the tumor immediately, followed by chemotherapy, might effectively treat localized high-grade osteosarcoma. This method offers hope for those newly diagnosed with this type of cancer.23456

Who Is on the Research Team?

AL

Alice Lee, M.D.

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a new, high-grade osteosarcoma in my limb and plan to have surgery followed by chemotherapy.
I can take care of myself but may not be able to do active work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection

Participants undergo upfront surgical resection of the tumor

1 week

Chemotherapy

Participants receive systemic multi-agent cytotoxic chemotherapy

6-12 months

Follow-up

Participants are monitored for functional outcomes and event-free survival

1-2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Upfront Surgical Resection

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: OsteosarcomaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39302698/

Effect of chemotherapy and surgery timing on mortality in ...

Results: Adjusted 5-year survival was 74% for surgery first patients and 67% for neoadjuvant first patients, with a survival difference of 6.9% ...

Upfront surgical resection for primary bone tumors: rationale ...

Furthermore, recent EURAMOS-1 results have shown that the ability to improve osteosarcoma outcomes by the addition of cytotoxic agents has ...

Upfront Surgical Resection for the Treatment of Localized ...

Upfront surgical resection followed by chemotherapy may improve functional outcomes and/or be effective in treating patients with localized high-grade ...

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The overall survival at 5 years after recurrence of OS ranges from 16% to 23% in most studies, highlighting the need for novel treatment approaches. Aggressive ...

Upfront Surgical Resection for Osteosarcoma

This prospective, non-randomized pilot study will assess patient-reported functional outcomes of upfront surgical resection in patients with ...

Upfront Surgical Resection for Osteosarcoma

This prospective, non-randomized pilot study will assess patient-reported functional outcomes of upfront surgical resection in patients with newly diagnosed, ...