Transcatheter Intra-arterial Limb Infusion of Cisplatin for Extremity Osteosarcoma

NCT03909776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2021-01-05

No results posted yet for this study

Summary

Although there seems to be no benefit from improving the histologic response rate or long-term survival of intra-arterial infusion of cisplatin for localized osteosarcoma of extremities with IOR/OS-3, IOR/OS-5, and COSS 86 protocols, such a treatment strategy is still believed to potentially increase the tumoricidal effect with an increase in higher local concentrations of the infused agents combined with longer tissue exposure time. Besides, the relationship of chemotherapy-induced necrosis and surgical margins is still the main concern for localized osteosarcoma patients to achieve long-term survival. The investigators intend to analyze the gain and loss from transcatheter intra-arterial limb infusion of cisplatin for extremity osteosarcoma in the past six years.

Conditions

  • Event-free Survival
  • Overall Survival
  • Local-recurrence Free Survival
  • Pathological Response

Interventions

DRUG

Cisplatin

Cisplatin was administered intravenously or intraarterially after adequate IV hydration. For IA infusion, cisplatin was given via insertion of a catheter percutaneously by using the Seldinger technique through the brachial or femoral artery under anesthesia and usually at 120 mg/m2 as a 3-h/6-h continuous infusion; while for IV administration, it was given at 100-120 mg/m2 as 6-h infusions.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Wei Guo, M.D. and Ph.D. · Musculoskeletal Tumor Center of Peking University People's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-04-01
Completion
2019-04-08

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909776 on ClinicalTrials.gov