Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
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.
|Endometrial Cancer Kidney Cancer Ovarian Cancer Pheochromocytoma Sarcoma||Biological: filgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: isolated perfusion Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA|
|Study Start Date:||February 1995|
|Study Completion Date:||June 2012|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002641
Hide Study Locations
|Graz, Austria, A-8010|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Hopital Universitaire Erasme|
|Brussels, Belgium, 1070|
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Island Cancer Centre|
|Victoria, British Columbia, Canada, V8R 6V5|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, New Brunswick|
|Saint John Regional Hospital|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 1C4|
|Mount Sinai Hospital - Toronto|
|Toronto, Ontario, Canada, M5G 1X5|
|Montreal, Quebec, Canada, H1T 2M4|
|Montreal, Quebec, Canada, H2W 1S6|
|Aarhus, Denmark, DK-8000|
|Copenhagen, Denmark, 2100|
|Centre Leon Berard|
|Lyon, France, 69373|
|CHU de la Timone|
|Marseille, France, 13385|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Robert Roessle Klinik|
|Berlin, Germany, D-13122|
|Essen, Germany, D-45122|
|Hamburg, Germany, D-20246|
|Munich, Germany, D-81377|
|Eberhard Karls Universitaet|
|Tuebingen, Germany, D-72076|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Milano (Milan), Italy, 20133|
|Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9713 EZ|
|Daniel Den Hoed Cancer Center at Erasmus University Medical Center|
|Rotterdam, Netherlands, 3075 EA|
|Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa|
|Lisbon, Portugal, 1099-023 Codex|
|National Cancer Institute - Bratislava|
|Bratislava, Slovakia, 833 10|
|Hospital de la Santa Cruz I Sant Pau|
|Barcelona, Spain, 08025|
|Bern, Switzerland, CH-3010|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|St. James's Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Royal Marsden NHS Trust - London|
|London, England, United Kingdom, SW3 6JJ|
|Middlesex Hospital- Meyerstein Institute|
|London, England, United Kingdom, WIT 3AA|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Study Chair:||Penella J. Woll, MD, PhD||Cancer Research Centre at Weston Park Hospital|
|Study Chair:||Vivien H.C. Bramwell, MB, BS, PhD, FRCP||Tom Baker Cancer Centre - Calgary|