Number of Participants With Unacceptable Toxicity After all patients have completed therapy, up to 1 year after last patient is enrolled [clinicaltrials_resource:e84ef67fbecde36ee6e991b53387a948]
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.
The 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.
A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.
clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]
Number of Participants With Unacceptable Toxicity After all patients have completed therapy, up to 1 year after last patient is enrolled [clinicaltrials_resource:e84ef67fbecde36ee6e991b53387a948]
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.
The 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.
A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.
Bio2RDF identifier
e84ef67fbecde36ee6e991b53387a948
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:e84ef67fbecde36ee6e991b53387a948
measure [clinicaltrials_vocabulary:measure]
Number of Participants With Unacceptable Toxicity
time frame [clinicaltrials_vocabulary:time-frame]
After all patients have completed therapy, up to 1 year after last patient is enrolled
description
Objective: To study the feasib ...... itoring unacceptable toxicity.
identifier
clinicaltrials_resource:e84ef67fbecde36ee6e991b53387a948
title
Number of Participants With Un ...... after last patient is enrolled
@en
type
label
Number of Participants With Un ...... ef67fbecde36ee6e991b53387a948]
@en