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:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00091351
Brief Summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy.
PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.
Detailed Description:
OBJECTIVES:
Primary
* Compare progression-free survival of patients with primary soft tissue sarcoma of the retroperitoneum or pelvis treated with surgery with vs without preoperative radiotherapy.
Secondary
* Compare the toxicity and complications associated with these regimens in these patients.
* Compare the rate of microscopically complete surgical resection in patients treated with these regimens.
* Compare the overall survival rate of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor grade (low \[G1\] vs intermediate \[G2\] vs high \[G3/4\]), tumor size (\< 15 cm vs ≥ 15 cm), and tumor histology (liposarcoma vs non-liposarcoma). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo surgery.
* Arm II: Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 4.5 years.
Study:
NCT00091351
Study Brief:
Protocol Section:
NCT00091351