{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 4 Hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 4 Proteinuria"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 4 Bleeding"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 3/4 Thrombosis/Embolism"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}]}],"title":"Grade 2, 3 or 4 Major Wound Complication"}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma.\n\nThe target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications.\n\nA six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.","groups":[{"description":"Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.","id":"OG000","title":"A: Localized Resectable Disease"},{"description":"Stratum C participants had metastatic tumors.","id":"OG001","title":"C: Metastatic Tumors"}],"paramType":"NUMBER","populationDescription":"Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.","reportingStatus":"POSTED","timeFrame":"After all patients have completed therapy, up to 1 year after last patient is enrolled","title":"Number of Participants With Unacceptable Toxicity","type":"PRIMARY","unitOfMeasure":"participants"}