Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004123
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-12-10
Brief Title:
Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Preoperative Chemoradiation and Intraoperative Radiation Therapy in the Treatment of Retroperitoneal Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-07
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of preoperative external beam radiotherapy when combined with doxorubicin and followed by intraoperative radiotherapy in patients with resectable primary or recurrent soft tissue sarcoma of the retroperitoneum II Assess radiologic and pathologic response in patients treated with this preoperative regimen
OUTLINE This is a dose-escalation study of external beam radiotherapy Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks Patients with stable or responding disease undergo surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after completion of chemoradiotherapy Patients receive intraoperative radiotherapy IORT to the tumor bed if all gross disease has been resected and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within a single IORT field maximum 15 cm Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 30 of patients experience grade 3 or worse dose-limiting toxicity
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study
OUTLINE This is a dose-escalation study of external beam radiotherapy Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks Patients with stable or responding disease undergo surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after completion of chemoradiotherapy Patients receive intraoperative radiotherapy IORT to the tumor bed if all gross disease has been resected and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within a single IORT field maximum 15 cm Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 30 of patients experience grade 3 or worse dose-limiting toxicity
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study
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-95225 | OTHER | None | None |
| NCI-G99-1606 | None | None | None |
| CDR0000067350 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |