Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002791
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY AND RADIATION THERAPY IN THE MANAGEMENT OF HIGH-RISK HIGH-GRADE SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND BODY WALL
Status:
COMPLETED
Status Verified Date:
2014-01
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:
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 radiation therapy with more than one chemotherapy drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma
Detailed Description:
OBJECTIVES I Assess whether patients with high-grade soft tissue sarcoma STS treated with neoadjuvant mesnadoxorubicinifosfamidedacarbazine MAID plus radiotherapy in a cooperative group setting exhibit a response rate toxicity and complication rate comparable to those seen in pilot data collected by the Massachusetts General Hospital II Assess local control and local complications related to surgery and neoadjuvant MAID plus radiotherapy in these patients III Develop a tissue repository of frozen STS for ancillary genetic and flow cytometric analysis of these tumors IV Form an Intergroup Working Sarcoma Group that will develop a patient base relationships and support for the future development and completion of a phase III study of adjuvant therapy for STS
OUTLINE The following acronyms are used DOX Doxorubicin NSC-123127 DTIC Dacarbazine NSC-45388 EBRT External-Beam Radiotherapy equipment unspecified G-CSF Filgrastim Granulocyte Colony-Stimulating Factor Amgen NSC-614629 IFF Ifosfamide NSC-109724 MAID MesnaDOXIFFDTIC Mesna Mercaptoethane sulfonate NSC-113891 3-Drug Combination Chemotherapy plus Radiotherapy followed by Surgery followed if indicated by Radiotherapy followed by 3-Drug Combination Chemotherapy MAID plus EBRT to the primary tumor and suspected microscopic disease followed by minimal wide surgical excision followed if positive margins by postoperative EBRT followed by MAID
PROJECTED ACCRUAL There will be 60 patients accrued into this study within 15 months
OUTLINE The following acronyms are used DOX Doxorubicin NSC-123127 DTIC Dacarbazine NSC-45388 EBRT External-Beam Radiotherapy equipment unspecified G-CSF Filgrastim Granulocyte Colony-Stimulating Factor Amgen NSC-614629 IFF Ifosfamide NSC-109724 MAID MesnaDOXIFFDTIC Mesna Mercaptoethane sulfonate NSC-113891 3-Drug Combination Chemotherapy plus Radiotherapy followed by Surgery followed if indicated by Radiotherapy followed by 3-Drug Combination Chemotherapy MAID plus EBRT to the primary tumor and suspected microscopic disease followed by minimal wide surgical excision followed if positive margins by postoperative EBRT followed by MAID
PROJECTED ACCRUAL There will be 60 patients accrued into this study within 15 months
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 |
|---|---|---|---|
| RTOG-R9514 | None | None | None |
| CDR0000064856 | None | None | None |
| E-R9514 | None | None | None |