Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis

Phase 3

Completed

• Conditions: Sarcoma

• Registration Number: NCT00091351
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-09-07
• Study First Submitted QC: 2004-09-08
• Study First Posted: 2004-09-09
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-free survival at 5 years	at 5 years

Trial Locations

Locations (59)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

George Washington University Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida Shands Cancer Center; 🇺🇸 Gainesville, Florida, United States

Phoebe Cancer Center at Phoebe Putney Memorial Hospital; 🇺🇸 Albany, Georgia, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States

Rush-Copley Cancer Care Center; 🇺🇸 Aurora, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States

Joliet Oncology Hematology Associates, Limited - West; 🇺🇸 Joliet, Illinois, United States

Scroll for more (49 remaining)