Apatinib + Ifosfamide and Etoposide for Relapsed or Refractory Osteosarcoma

Sponsor
Peking University People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04690231
Collaborator
Peking University Shougang Hospital (Other)
79
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Today, using a multi-modal approach consisting of preoperative (neoadjuvant) systemic polychemotherapy followed by local surgical therapy and then postoperative (adjuvant) chemotherapy, long-term, disease-free survival can be achieved in 60- 70% of osteosarcoma patients. However treatment options for osteosarcomas, especially in the setting of metastatic or unresectable disease, are very scarce. Apatinib has been proved to be an effective agent to prolong progression-free survival in advanced osteosarcoma. But after 4-6 months' treatment, secondary resistance always occurred with musculoskeletal lesions' progression or new metastasis.

Nowadays giving therapeutic doses of IE concurrently with anti-angiogenesis tyrosine kinase inhibitors is a conceptually attractive strategy for treating patients with refractory osteosarcoma according to prospective trial of lenvatinib +IE reported by Gaspar et al at 2019 ESMO and 2020 ESMO. Thus This study was designed to review our experience in real world for off-label use and characterize the toxicity profile of concurrent apatinib+IE and IE alone in patients with relapsed or refractory osteosarcoma.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Apatinib Mesylate
  • Drug: ifosfamide and etoposide
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Apatinib+Ifosfamide and Etoposide (IE) Versus IE Alone for Relapsed or Refractory Osteosarcoma: a Real-world Study in Two Centers in China
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Apatinib+IE

Drug: Apatinib Mesylate
apatinib orally daily and ifosfamide 1.8mg/m2/d d1-3, etoposide 100mg/m2/d d1-3
Other Names:
  • ifosfamide and etoposide
  • Drug: ifosfamide and etoposide
    ifosfamide and etoposide

    Active Comparator: IE

    Drug: ifosfamide and etoposide
    ifosfamide and etoposide

    Outcome Measures

    Primary Outcome Measures

    1. event-free survival [24 months]

      from start treatment to any events/death

    Secondary Outcome Measures

    1. progression-free survival [24 months]

      from start treatment to progression/death

    2. overall survival [24 months]

      from start treatment to death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • histological diagnosis of osteosarcoma (confirmed by central pathological review by an expert pathologist from the Peking University People's Hospital)

    • objective disease progression within 3 months prior to treatment according to RECIST 1.1

    • previously treated with one to two lines of chemotherapy for metastatic disease

    • have an adequate performance status (adults:Eastern Cooperative Oncology Group [ECOG] performance status of 0-1;children aged >12 years: a score of ≥60% on the Karnofsky performance scale; children aged ≤12 years a score of ≥60% on the Lansky scale)

    Exclusion Criteria:
    • a life expectancy of less than 3 months

    • patients had to have adequate bone marrow function, normal renal function, normal liver function, and normal pancreatic function

    • no other malignant tumors

    • no malignant pleural and peritoneal effusion

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Peking University People's HospitalBeijingBeijingChina100044

    Sponsors and Collaborators

    • Peking University People's Hospital
    • Peking University Shougang Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04690231
    Other Study ID Numbers:
    • PKUPH-sarcoma 14
    First Posted:
    Dec 30, 2020
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking University People's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2022