NCT00002641

Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma

RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 16 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.

Detailed description

OBJECTIVES: * Compare the local disease control, overall survival, and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after definitive surgery. * Compare the toxicity and morbidity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head, or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no). Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines. No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery. Patients with complete resection undergo radiotherapy assessment and then randomization. Patients with incomplete or marginal resection (except for central lesions) undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative radiotherapy followed by randomization. * Randomization: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined below. * Arm II: Beginning within 4 weeks after surgery, patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days. Treatment continues every 3 weeks for 5 courses. Beginning within 6 weeks after completion of chemotherapy, eligible patients undergo radiotherapy as outlined below. * Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-6.6 weeks. Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week. Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.

Conditions

• Endometrial Cancer
• Kidney Cancer
• Ovarian Cancer
• Pheochromocytoma
• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	doxorubicin hydrochloride
DRUG	ifosfamide
DRUG	isolated perfusion
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 1995-02-01
• Primary completion: 2006-02-01
• Completion: 2012-06-01
• First posted: 2003-01-27
• Last updated: 2014-08-08

Locations

45 sites across 13 countries: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, Slovakia, Spain, Switzerland, United Kingdom