Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002804
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Surgery and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Phase II Study of Neoadjuvant Vincristine Ifosfamide Doxorubicin and AND G-CSF in Children With Advanced Stage Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2014-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy surgery and radiation therapy in treating children who have advanced soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy surgery and radiation therapy in treating children who have advanced soft tissue sarcoma
Detailed Description:
OBJECTIVES I Assess the response to vincristineifosfamidedoxorubicin VID with granulocyte colony-stimulating factor support in children with newly diagnosed inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas II Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy andor surgery III Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies
OUTLINE The following acronyms are used DOX Doxorubicin NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 IFF Ifosfamide NSC-109724 Mesna Mercaptoethane sulfonate NSC-113891 VCR Vincristine NSC-67574 VID VCRIFFDOX Induction 3-Drug Combination Chemotherapy VID Local Control Surgery andor Radiotherapy plus 3-Drug Combination Chemotherapy Excision of the primary tumor and pulmonary metastases andor irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV electrons or iridium-192 implant allowed for boost plus VID Continuation 3-Drug Combination Chemotherapy VID
PROJECTED ACCRUAL A total of 40 patients will be entered over 27 years if there are at least 7 responses in the first 20 patients
OUTLINE The following acronyms are used DOX Doxorubicin NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 IFF Ifosfamide NSC-109724 Mesna Mercaptoethane sulfonate NSC-113891 VCR Vincristine NSC-67574 VID VCRIFFDOX Induction 3-Drug Combination Chemotherapy VID Local Control Surgery andor Radiotherapy plus 3-Drug Combination Chemotherapy Excision of the primary tumor and pulmonary metastases andor irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV electrons or iridium-192 implant allowed for boost plus VID Continuation 3-Drug Combination Chemotherapy VID
PROJECTED ACCRUAL A total of 40 patients will be entered over 27 years if there are at least 7 responses in the first 20 patients
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 |
|---|---|---|---|
| COG-P9953 | OTHER | Childrens Oncology Group | None |
| POG-9553 | OTHER | None | None |
| CDR0000064905 | OTHER | None | None |