Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017160
Status:
WITHDRAWN
Last Update Posted:
2013-06-27
First Post:
2001-06-06
Brief Title:
Combination Chemotherapy Radiation Therapy and Surgery in Treating Patients With Primary or Recurrent Sarcoma
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide Radiotherapy and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma
Status:
WITHDRAWN
Status Verified Date:
2013-06
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 radiation therapy and surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and surgery in treating patients who have primary or recurrent sarcoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and surgery in treating patients who have primary or recurrent sarcoma
Detailed Description:
OBJECTIVES
Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide radiotherapy and surgical resection
Assess local-regional control in patients treated with this regimen
Determine the disease-free survival of patients treated with this regimen
Determine the pathologic response in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the complications in patients treated with this regimen
OUTLINE Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4 Patients also receive filgrastim G-CSF beginning on day 5 and continuing until blood counts recover Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity Beginning 2-4 weeks after chemotherapy patients undergo radiotherapy daily 5 days a week for 5-6 weeks Beginning 4-7 weeks after radiotherapy patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within 24 months
Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide radiotherapy and surgical resection
Assess local-regional control in patients treated with this regimen
Determine the disease-free survival of patients treated with this regimen
Determine the pathologic response in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the complications in patients treated with this regimen
OUTLINE Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4 Patients also receive filgrastim G-CSF beginning on day 5 and continuing until blood counts recover Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity Beginning 2-4 weeks after chemotherapy patients undergo radiotherapy daily 5 days a week for 5-6 weeks Beginning 4-7 weeks after radiotherapy patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within 24 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 |
|---|---|---|---|
| CDR0000068657 | None | None | None |