Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03742193
Eligibility Criteria:
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 surgery
* pleural or peritoneal effusion that needs to be handled by surgical treatment;
* combined with other infections or wounds
* wound dystrophy, poor soft-tissue around implantation or other wound complications risky of non-healing given angiogenesis inhibitor assessed by the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
50 Years
Study:
NCT03742193
Study Brief:
Protocol Section:
NCT03742193