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

NCT00002641 | Completed Phase 3

• 2 other identifiers: EORTC-62931CAN-NCIC-SR3
• Study Type: interventional
• Target: 350
• Locations: 13 countries
• Sites: 45

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.

Conditions

Endometrial Cancer; Kidney Cancer; Ovarian Cancer; Pheochromocytoma; Sarcoma

Keywords

adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; adult alveolar soft-part sarcoma; adult epithelioid sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult malignant mesenchymoma; adult rhabdomyosarcoma; localized benign pheochromocytoma; regional pheochromocytoma; recurrent pheochromocytoma; stage II uterine sarcoma; stage III uterine sarcoma; recurrent uterine sarcoma; uterine carcinosarcoma; uterine leiomyosarcoma; endometrial stromal sarcoma; ovarian sarcoma; clear cell sarcoma of the kidney; stage II adult soft tissue sarcoma

Interventions

filgrastim BIOLOGICAL

doxorubicin hydrochloride DRUG

ifosfamide DRUG

isolated perfusion DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 16 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery * Eligible subtypes: * Alveolar soft part sarcoma * Angiosarcoma * Fibrosarcoma * Leiomyosarcoma * Malignant fibrous histiocytoma * Liposarcoma (round cell and pleomorphic) * Miscellaneous sarcoma (including pelvic mixed mesodermal tumors) * Malignant paraganglioma * Neurogenic sarcoma * Rhabdomyosarcoma * Synovial sarcoma * Unclassifiable sarcoma * Ineligible subtypes: * Chondrosarcoma * Dermatofibrosarcoma * Embryonal rhabdomyosarcoma * Ewing's sarcoma * Kaposi's sarcoma * Liposarcoma (myxoid and well differentiated) * Malignant mesothelioma * Neuroblastoma * Osteosarcoma * Confirmed high-grade tumor (i.e., Trojani Grade II or III) * No metastases on staging with chest x-ray and thoracic CT scan * No regional lymph node involvement * Locally recurrent disease allowed * Interval of 3 months or more between definitive surgery and recurrence PATIENT CHARACTERISTICS: Age: * 16 to 69 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 120,000/mm\^3 * No bleeding disorders Hepatic: * Bilirubin no greater than 1.25 times normal * No severe hepatic dysfunction Renal: * Creatinine less than 1.6 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No clear history of angina * No documented myocardial infarction * No existing cardiac failure Other: * No serious infection * No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to affected area Surgery: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• NCIC Clinical Trials Group: collaborator

Study Sites (45)

Karl-Franzens-University Graz

Graz, A-8010, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Aarhus Kommunehospital

Aarhus, DK-8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Robert Roessle Klinik

Berlin, D-13122, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Klinikum Grosshadern

Munich, D-81377, Germany

Location

Eberhard Karls Universitaet

Tübingen, D-72076, Germany

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), 20133, Italy

Location

Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus University Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

Lisbon, 1099-023 Codex, Portugal

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Hospital de la Santa Cruz I Sant Pau

Barcelona, 08025, Spain

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Marsden NHS Trust - London

London, England, SW3 6JJ, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Related Publications (2)

• Le Cesne A, Van Glabbeke M, Woll PJ, et al.: The end of adjuvant chemotherapy (adCT) era with doxorubicin-based regimen in resected high-grade soft tissue sarcoma (STS): pooled analysis of the two STBSG-EORTC phase III clinical trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-10525, 2008.

  BACKGROUND

• Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group and the NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. doi: 10.1016/S1470-2045(12)70346-7. Epub 2012 Sep 4.

  PMID: 22954508 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Kidney Neoplasms; Ovarian Neoplasms; Pheochromocytoma; Sarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Neurofibrosarcoma; Sarcoma, Synovial; Sarcoma, Alveolar Soft Part; Histiocytoma, Malignant Fibrous; Hemangiopericytoma, Malignant; Malignant mesenchymal tumor; Rhabdomyosarcoma; Sarcoma, Endometrial Stromal

Interventions

Filgrastim; Doxorubicin; Ifosfamide; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Neurofibroma; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Histiocytoma; Myosarcoma; Neoplasms, Complex and Mixed; Endometrial Stromal Tumors

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1995
• Primary Completion: February 1, 2006
• Study Completion: June 1, 2012
• Last Updated: August 8, 2014

Record last verified: 2002-07

Locations

DE (5); NL (3); PT (1); ES (1); DK (2); CH (3); GB (8); AU (1); FR (3); SL (1); BE (5); IT (1); CA (11)