Viewing Study NCT00001217



Ignite Creation Date: 2024-05-05 @ 9:36 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001217
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Osteosarcoma Study 2 A Randomized Trial of Pre-Surgical Chemotherapy vs Immediate Surgery and Adjuvant Chemotherapy in the Treatment of Non-Metastatic Osteosarcoma A Pediatric Oncology Group Phase III Study
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Osteosarcoma Study 2 A Randomized Trial of Pre-Surgical Chemotherapy vs Immediate Surgery and Adjuvant Chemotherapy in the Treatment of Non-Metastatic Osteosarcoma A Pediatric Oncology Group Phase III Study
Status: COMPLETED
Status Verified Date: 2000-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma both prior to and after the definitive surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed An effort will be made as well to determine if the administration of pre-definitive surgery chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure
Detailed Description: The study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma both prior to and after the definitive surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed An effort will be made as well to determine if the administration of pre-definitive surgery chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
87-C-0068 None None None