Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
- Conditions
- Ovarian CancerKidney CancerPheochromocytomaEndometrial CancerSarcoma
- Registration Number
- NCT00002641
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
Karl-Franzens-University Graz
🇦🇹Graz, Austria
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
CHU de la Timone
🇫🇷Marseille, France
Rigshospitalet
🇩🇰Copenhagen, Denmark
Centre Leon Berard
🇫🇷Lyon, France
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Aarhus Kommunehospital
🇩🇰Aarhus, Denmark
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Klinikum Grosshadern
🇩🇪Munich, Germany
Robert Roessle Klinik
🇩🇪Berlin, Germany
Institut Gustave Roussy
🇫🇷Villejuif, France
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Milano (Milan), Italy
Eberhard Karls Universitaet
🇩🇪Tuebingen, Germany
Universitaets-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
🇵🇹Lisbon, Portugal
National Cancer Institute - Bratislava
🇸🇰Bratislava, Slovakia
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Hospital de la Santa Cruz I Sant Pau
🇪🇸Barcelona, Spain
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Royal Marsden NHS Trust - London
🇬🇧London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
St. James's Hospital
🇬🇧Leeds, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom