CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,334 enrolled
Drug / intervention
Cisplatin +8 moredrug
Likely dose
Cisplatin, doxorubicin, etoposide, ifosfamide, and methotrexate IV; peginterferon alfa-2b subcutaneously (specific doses not stated)AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed high-grade osteosarcoma, including second malignancies
  • ✓Localized or metastatic disease
  • ✓Primary tumor in limbs or axial skeleton (long/short bones of limbs, vertebral column, ribs/sternum/clavicle/scapula, pelvis/sacrum/coccyx)
  • ✓Tumor resectable or expected to become resectable after neoadjuvant chemotherapy
Key exclusion· 5
  • ✕Craniofacial osteosarcoma
  • ✕Prior chemotherapy for any disease
  • ✕Prior treatment for osteosarcoma
  • ✕Known HIV positivity

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

Search/NCT00134030
NCT00134030Phase 3Completed
CompareCT.gov

A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy

Children's Oncology Group·interventional·Posted Aug 24, 2005·Updated Jun 7, 2023

In Brief

A Phase 3 clinical trial evaluating Cisplatin, Doxorubicin Hydrochloride, and 7 other interventions for Localized Osteosarcoma and Metastatic Osteosarcoma. Completed, enrolled 1,334 participants across 218 sites in 6 countries.

Detailed Summary

This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocalized Osteosarcoma, Metastatic Osteosarcoma
CountriesAustralia, Canada, New Zealand, Puerto Rico, Switzerland, United States
CollaboratorsNational Cancer Institute (NCI), University College, London, Medical Research Council

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2005
Enrollment StartNov 14, 2005
Primary CompletionJan 31, 2015
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 20.9 years ago

Interventions

Cisplatindrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Ifosfamidedrug

Given IV

Methotrexatedrug

Given IV

Peginterferon Alfa-2bbiological

Given subcutaneously

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Therapeutic Conventional Surgeryprocedure

Undergo amputation or limb salvage surgery