Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023725
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-09-13
Brief Title:
Radiation Therapy With or Without SU5416 in Treating Patients With Soft Tissue Sarcoma
Sponsor:
Radiation Therapy Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Study Of Preoperative Radiotherapy WithWithout SUGEN 5416 NSC 696819 A TK Inhibitor Anti-Angiogenesis Compound In The Management Of Low To Intermediate Grade Soft Tissue Sarcoma Of The Trunk or Extremity
Status:
COMPLETED
Status Verified Date:
2007-08
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor It is not yet known if radiation therapy is more effective with or without SU5416 in treating soft tissue sarcoma
PURPOSE Phase III trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma
PURPOSE Phase III trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of SU5416 when combined with neoadjuvant radiotherapy in patients with stage IB or IIA soft tissue sarcoma
Determine the antiangiogenic effects of SU5416 in these patients
Determine any synergistic antiangiogenic effect of SU5416 with radiotherapy in these patients
Compare the disease-free survival local recurrence distant metastases and overall survival rates in patients treated with neoadjuvant radiotherapy with or without SU5416
OUTLINE This is a phase I dose-escalation study of SU5416 followed by a phase II randomized study
Phase I
Patients undergo radiotherapy once daily 5 days a week for 5 weeks Patients also receive SU5416 IV over 1 hour twice weekly beginning on week 1 and continuing until 2 days before surgery
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
Phase II
Once the MTD has been determined additional patients are accrued and then randomized to receive either treatment as in phase I at the MTD vs preoperative radiotherapy alone
All patients undergo surgical resection 70-80 days after beginning therapy Patients with positive surgical margins receive additional radiotherapy daily for 8 days and SU5416 IV over 1 hour on days 2 4 and 9
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 18 patients will be accrued for phase I of this study within 1 year Approximately 28 patients will be accrued for phase II of this study
Determine the maximum tolerated dose of SU5416 when combined with neoadjuvant radiotherapy in patients with stage IB or IIA soft tissue sarcoma
Determine the antiangiogenic effects of SU5416 in these patients
Determine any synergistic antiangiogenic effect of SU5416 with radiotherapy in these patients
Compare the disease-free survival local recurrence distant metastases and overall survival rates in patients treated with neoadjuvant radiotherapy with or without SU5416
OUTLINE This is a phase I dose-escalation study of SU5416 followed by a phase II randomized study
Phase I
Patients undergo radiotherapy once daily 5 days a week for 5 weeks Patients also receive SU5416 IV over 1 hour twice weekly beginning on week 1 and continuing until 2 days before surgery
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
Phase II
Once the MTD has been determined additional patients are accrued and then randomized to receive either treatment as in phase I at the MTD vs preoperative radiotherapy alone
All patients undergo surgical resection 70-80 days after beginning therapy Patients with positive surgical margins receive additional radiotherapy daily for 8 days and SU5416 IV over 1 hour on days 2 4 and 9
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 18 patients will be accrued for phase I of this study within 1 year Approximately 28 patients will be accrued for phase II of 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-0120 | None | None | None |