Pulmonary Resectable Metastases of Osteosarcoma With Anti-angiogenics and CHemotherapy (NCT03742193) | Clinical Trial Compass
UnknownPhase 2
Pulmonary Resectable Metastases of Osteosarcoma With Anti-angiogenics and CHemotherapy
China43 participantsStarted 2019-08-11
Plain-language summary
The aim of this study is to evaluate the efficacy and safety of Second-line chemotherapy combined with Apatinib for the patients with resectable pulmonary metastasis of osteosarcoma.
Who can participate
Age range10 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age between 10 and 50 years;
* diagnosis of histologically confirmed high grade osteosarcoma;
* identification of pulmonary metastases without the existence of local recurrence(previous re-resection of local recurrence with wide margin is allowed).
* resectable pulmonary nodule(s), defined as nodule(s) that are removable by wedge resection/ segmentectomy/lobectomy without necessitating a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels)
* prior treatment consisted of standard National Comprehensive Cancer Network (NCCN) guideline recommended first-line chemotherapy
* wide/radical-margin surgical resection of the primary tumor completed at least 4 weeks before enrollment.
* Eastern Cooperative Oncology Group(ECOG) performance status 0-2 with a life expectancy \>3 months;
* adequate renal, hepatic, and hemopoietic function;
* normal or controlled blood pressure;
* no thoracic comorbidities with adequate pulmonary function eligible for thoracic surgery
Exclusion Criteria:
* previously exposed to GD chemotherapy or VEGFR2 Tyrosine-kinase inhibitors (TKIs);
* existence of local recurrence;
* have had other kinds of malignant tumors at the same time;
* cardiac insufficiency or arrhythmia;
* uncontrolled complications, such as diabetes mellitus and so on;
* coagulation disorders or Hemorrhagic diseases ;
* metastases considered unresectable or borderline resectable at baseline
* intolerable of thoracis sur…
What they're measuring
1
12 months Progression-free survival rate(12mPFR)
Timeframe: 12 months from the recruitment of the study