CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Ifosfamide, Carboplatin, Doxorubicin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00145639
NCT00145639Phase 2Completed
CompareCT.gov

Osteosarcoma 1999-A Study Of Intensive Chemotherapy Utilizing Ifosfamide, Carboplatin, and Doxorubicin for Adjuvant Chemotherapy for Treatment of Osteosarcoma

St. Jude Children's Research Hospital·interventional·Posted Sep 5, 2005·Updated Jun 10, 2011

In Brief

A Phase 2 clinical trial evaluating Ifosfamide, Carboplatin, Doxorubicin and Limb Sparing for Osteosarcoma. Completed, enrolled 80 participants across 4 sites in 2 countries.

Detailed Summary

This trial (OS99) evaluates the use of ifosfamide, carboplatin, and doxorubicin in an up-front window before surgery for localized and resectable osteosarcoma. High-dose methotrexate, which may interfere with the dose-intensive delivery of other agents, is eliminated from the treatment of localized disease. The primary objective is to compare the response rate of pre-surgical chemotherapy comprised of ifosfamide, doxorubicin, and carboplatin to that obtained with ifosfamide and carboplatin in the St. Jude OS-91 trial for patients with non-metastatic resectable osteosarcoma. We hypothesize that the histologic response rate will be improved by the addition of one course of pre-operative chemotherapy on this trial compared to the previous OS-91 trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteosarcoma
CountriesChile, United States
CollaboratorsImmunex/Berlex, National Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartMay 1, 1999
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 20.8 years ago

Interventions

Ifosfamide, Carboplatin, Doxorubicindrug

See Detailed Description for treatment plan.

Limb Sparingprocedure

See Detailed Description for treatment plan.