Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023738
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-09-13
Brief Title:
Chemotherapy SU5416 Radiation Therapy and Surgery in Treating Patients With Soft Tissue Sarcoma
Sponsor:
Radiation Therapy Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Of Neoadjuvant Chemotherapy Angiogenesis Inhibitor SU5416 NSC 696819 A TK Inhibitor Anti-Angionesises Compound 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:
2010-12
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 Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor Radiation therapy uses high-energy x-rays to damage tumor cells Giving chemotherapy SU5416 and radiation therapy before and after surgery may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of chemotherapy SU5416 radiation therapy and surgery in treating patients who have soft tissue sarcoma
PURPOSE Phase III trial to study the effectiveness of chemotherapy SU5416 radiation therapy and surgery in treating patients who have soft tissue sarcoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of SU5416 when administered with neoadjuvant chemotherapy and radiotherapy and adjuvant chemotherapy in patients with high-grade stage IIC-III soft tissue sarcoma
Determine the disease-free survival local control and overall survival in patients treated with this regimen
Determine histological response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quantitative antiangiogenic effects of SU5416 in patients treated with this regimen
OUTLINE This is a dose-escalation study of SU5416
Patients receive neoadjuvant chemotherapy comprising doxorubicin ifosfamide and dacarbazine IV continuously on days 1-3 22-24 and 43-45 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 5 and continuing until blood counts recover Patients undergo 2 courses of radiotherapy given once daily for 11 doses per course over days 7-20 and 28-41 Patients also receive SU5416 IV over 1 hour twice weekly beginning on day 1 and continuing until 2 days before surgery Patients undergo surgical resection on day 80 Patients then receive adjuvant chemotherapy comprising doxorubicin ifosfamide and dacarbazine IV continuously on days 101-103 122-124 and 143-145 Patients also receive SU5416 IV over 1 hour twice weekly beginning on day 101 and continuing until the end of adjuvant chemotherapy Patients with positive surgical margins receive additional radiotherapy beginning 2 weeks after resection for a total of 8 doses
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 68-80 patients will be accrued for this study
Determine the maximum tolerated dose of SU5416 when administered with neoadjuvant chemotherapy and radiotherapy and adjuvant chemotherapy in patients with high-grade stage IIC-III soft tissue sarcoma
Determine the disease-free survival local control and overall survival in patients treated with this regimen
Determine histological response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quantitative antiangiogenic effects of SU5416 in patients treated with this regimen
OUTLINE This is a dose-escalation study of SU5416
Patients receive neoadjuvant chemotherapy comprising doxorubicin ifosfamide and dacarbazine IV continuously on days 1-3 22-24 and 43-45 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 5 and continuing until blood counts recover Patients undergo 2 courses of radiotherapy given once daily for 11 doses per course over days 7-20 and 28-41 Patients also receive SU5416 IV over 1 hour twice weekly beginning on day 1 and continuing until 2 days before surgery Patients undergo surgical resection on day 80 Patients then receive adjuvant chemotherapy comprising doxorubicin ifosfamide and dacarbazine IV continuously on days 101-103 122-124 and 143-145 Patients also receive SU5416 IV over 1 hour twice weekly beginning on day 101 and continuing until the end of adjuvant chemotherapy Patients with positive surgical margins receive additional radiotherapy beginning 2 weeks after resection for a total of 8 doses
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 68-80 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 |
|---|---|---|---|
| RTOG-S-0121 | None | None | None |