Clinical Trial: Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma

This study is no longer recruiting patients.

Sponsors and Collaborators: EORTC Soft Tissue and Bone Sarcoma Cooperative Group
National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
adult soft tissue sarcoma
clear cell sarcoma of the kidney
ovarian sarcoma
Pheochromocytoma
uterine sarcoma
 Drug: doxorubicin
 Drug: filgrastim
 Drug: ifosfamide
 Procedure: adjuvant therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: conventional surgery
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: isolated perfusion
 Procedure: radiation therapy
 Procedure: surgery
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Kidney Cancer;   Pheochromocytoma;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Adjuvant High-Dose Doxorubicin and Ifosfamide Plus Filgrastim (G-CSF) Versus No Adjuvant Chemotherapy and G-CSF After Definitive Surgery in Patients With High-Grade Soft Tissue Sarcoma

Further Study Details: 

OBJECTIVES:

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.

  • 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.

Eligibility

Ages Eligible for Study:  16 Years   -   69 Years,  Genders Eligible for Study:  Both

Criteria

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:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

Endocrine therapy:

  • Not specified

Radiotherapy:

Surgery:

  • See Disease Characteristics

Location Information


Austria
      Karl-Franzens-University Graz, Graz,  A-8010,  Austria

Belgium
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium

      Hopital Universitaire Erasme, Brussels,  1070,  Belgium

      Institut Jules Bordet, Brussels,  1000,  Belgium

      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium

      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada

      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada

Canada, British Columbia
      British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria,  British Columbia,  V8R 6V5,  Canada

Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada

Canada, New Brunswick
      Saint John Regional Hospital, Saint John,  New Brunswick,  E2L 4L2,  Canada

Canada, Ontario
      Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada

      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada

      Mount Sinai Hospital - Toronto, Toronto,  Ontario,  M5G 1X5,  Canada

      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada

Canada, Quebec
      Maisonneuve-Rosemont Hospital, Montreal,  Quebec,  H1T 2M4,  Canada

      McGill University, Montreal,  Quebec,  H2W 1S6,  Canada

Denmark
      Aarhus Kommunehospital, Aarhus,  DK-8000,  Denmark

      Rigshospitalet, Copenhagen,  2100,  Denmark

France
      Centre Leon Berard, Lyon,  69373,  France

      CHU de la Timone, Marseille,  13385,  France

      Institut Gustave Roussy, Villejuif,  F-94805,  France

Germany
      Eberhard Karls Universitaet, Tuebingen,  D-72076,  Germany

      Klinikum Grosshadern, Munich,  D-81377,  Germany

      Robert Roessle Klinik, Berlin,  D-13122,  Germany

      Universitaetsklinikum Essen, ESSEN,  D-45122,  Germany

      Universitaets-Krankenhaus Eppendorf, Hamburg,  D-20246,  Germany

Italy
      Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano (Milan),  20133,  Italy

Netherlands
      Academisch Ziekenhuis Groningen, Groningen,  9713 EZ,  Netherlands

      Antoni van Leeuwenhoek Hospital, Amsterdam,  1066 CX,  Netherlands

      Daniel Den Hoed Cancer Center at Erasmus University Medical Center, Rotterdam,  3075 EA,  Netherlands

Portugal
      Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa, Lisbon,  1099-023 Codex,  Portugal

Slovakia
      National Cancer Institute - Bratislava, Bratislava,  833 10,  Slovakia

Spain
      Hospital de la Santa Cruz I Sant Pau, Barcelona,  08025,  Spain

Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland

      Inselspital, Bern, Bern,  CH-3010,  Switzerland

      Kantonsspital - St. Gallen, St. Gallen,  CH-9007,  Switzerland

United Kingdom, England
      Christie Hospital N.H.S. Trust, Manchester,  England,  M20 4BX,  United Kingdom

      Middlesex Hospital- Meyerstein Institute, London,  England,  WIT 3AA,  United Kingdom

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

      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom

      Royal Devon and Exeter Hospital, Exeter,  England,  EX2 5DW,  United Kingdom

      Royal Marsden NHS Trust - London, London,  England,  SW3 6JJ,  United Kingdom

      St. James's Hospital, Leeds,  England,  LS9 7TF,  United Kingdom

      Weston Park Hospital, Sheffield,  England,  S1O 2SJ,  United Kingdom

Study chairs or principal investigators

Penella Woll, MD, PhD,  Weston Park Hospital   
Vivien H.C. Bramwell, MB, BS, PhD, FRCP,  Study Chair,  Tom Baker Cancer Center - Calgary   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064132; EORTC-62931; CAN-NCIC-SR3
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002641
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005