Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091351
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2004-09-07
Brief Title:
Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas RPS
Status:
COMPLETED
Status Verified Date:
2016-07
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 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
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 G34 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 55 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 45 years
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 G34 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 55 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 45 years
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 |
|---|---|---|---|
| CDR0000387803 | REGISTRY | NCI Physician Data Query | None |
| ACOSOG-Z9031 | None | None | None |