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

August 7, 2014 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8010
        • Karl-Franzens-University Graz
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Cancer Care Ontario-Hamilton Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus Kommunehospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Lyon, France, 69373
        • Centre LEON BERARD
      • Marseille, France, 13385
        • CHU de la Timone
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, D-13122
        • Robert Roessle Klinik
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen
      • Hamburg, Germany, D-20246
        • Universitaets-Krankenhaus Eppendorf
      • Munich, Germany, D-81377
        • Klinikum Großhadern
      • Tuebingen, Germany, D-72076
        • Eberhard Karls Universitaet
  • Italy
      • Milano (Milan), Italy, 20133
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoek Hospital
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Rotterdam, Netherlands, 3075 EA
        • Daniel Den Hoed Cancer Center at Erasmus University Medical Center
  • Portugal
      • Lisbon, Portugal, 1099-023 Codex
        • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Cancer Institute - Bratislava
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz i Sant Pau
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
  • United Kingdom
    • England
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • St. James's Hospital
      • London, England, United Kingdom, WIT 3AA
        • Middlesex Hospital- Meyerstein Institute
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust - London
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital N.H.S. Trust
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Weston Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

NCIC Clinical Trials Group

Investigators

  • Study Chair: Vivien H.C. Bramwell, MB, BS, PhD, FRCP, Tom Baker Cancer Centre - Calgary
  • Study Chair: Penella J. Woll, MD, PhD, Cancer Research Centre at Weston Park Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1995

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

July 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-62931
  • CAN-NCIC-SR3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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