Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00017160
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.
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.
Study:
NCT00017160
Study Brief:
Protocol Section:
NCT00017160