Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004109
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
1999-12-10
Brief Title:
Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2012-08
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 chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma
PURPOSE Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of doxorubicin when combined with external beam radiotherapy in patients with high risk soft tissue sarcomas of the extremity or trunk II Assess the radiographic and pathologic response rates to this preoperative regimen in the subset of these patients with measurable disease
OUTLINE This is a dose escalation study of doxorubicin Patients receive doxorubicin intravenous IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks in the absence of unacceptable toxicity Patients with measurable disease receive external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin treatment Patients with measurable disease undergo surgical resection of the residual mass 4-7 weeks following completion of chemoradiation Patients who have no measurable disease and have undergone prereferral excision undergo surgical resection of the prior surgical scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks Cohorts of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose MTD is determined Patients are followed every 3 months for 3 years every 4 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study at a rate of 5-6 patients per month
OUTLINE This is a dose escalation study of doxorubicin Patients receive doxorubicin intravenous IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks in the absence of unacceptable toxicity Patients with measurable disease receive external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin treatment Patients with measurable disease undergo surgical resection of the residual mass 4-7 weeks following completion of chemoradiation Patients who have no measurable disease and have undergone prereferral excision undergo surgical resection of the prior surgical scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks Cohorts of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose MTD is determined Patients are followed every 3 months for 3 years every 4 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study at a rate of 5-6 patients per month
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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-ID-97335 | OTHER | None | None |
| NCI-G99-1598 | None | None | None |
| CDR0000067332 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |