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Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

This study has been completed.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC Identifier:
First received: June 5, 2003
Last updated: October 24, 2014
Last verified: October 2014

June 5, 2003
October 24, 2014
April 2003
May 2010   (final data collection date for primary outcome measure)
Overall survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00061984 on Archive Site
  • Response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
  • Treatment-related mortality [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma

RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.


  • Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy.
  • Compare the response in patients treated with these regimens.
  • Compare the treatment-related mortality of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).
  • Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Biological: pegfilgrastim
  • Drug: doxorubicin hydrochloride
  • Drug: ifosfamide
  • Procedure: multimodality therapy
Not Provided
Judson I, Verweij J, Gelderblom H, Hartmann JT, Schöffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litière S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
May 2010   (final data collection date for primary outcome measure)


  • Histologically confirmed soft tissue sarcoma

    • Locally advanced unresectable* OR metastatic disease
    • High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: *Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed
  • The following tumor types are eligible:

    • Malignant fibrous histiocytoma
    • Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma
    • Pleomorphic rhabdomyosarcoma
    • Synovial sarcoma
    • Myxofibrosarcoma, intermediate and high-grade
    • Fibrosarcoma
    • Leiomyosarcoma
    • Angiosarcoma
    • Malignant peripheral nerve sheath tumor
    • Epithelioid sarcoma
    • Alveolar rhabdomyosarcoma
    • Unclassifiable sarcoma, not otherwise specified
  • The following tumor types are not eligible:

    • Gastrointestinal stromal tumor
    • Mixed mesodermal tumor
    • Chondrosarcoma
    • Malignant mesothelioma
    • Neuroblastoma
    • Osteosarcoma
    • Ewing's sarcoma/primitive neuroectodermal tumor
    • Desmoplastic small round cell tumor
    • Embryonal rhabdomyosarcoma
    • Alveolar soft part sarcoma
  • Must have a measurable lesion with clinical evidence of progression within the past 6 weeks

    • Osseous lesions and pleural effusions are not considered measurable
  • No known or symptomatic CNS metastases



  • 18 to 60

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.8 mg/dL
  • Albumin at least 2.5 g/dL


  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance greater than 65 mL/min


  • No history of cardiovascular disease


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other severe medical illness
  • No psychosis
  • No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule


Biologic therapy

  • Not specified


  • No prior chemotherapy for advanced or metastatic disease
  • Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the sole index lesion


  • Not specified
18 Years to 60 Years
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Netherlands,   Slovakia,   Spain,   Switzerland,   United Kingdom
EORTC-62012, EORTC-62012
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Ian R. Judson, MA, MD, FRCP Institute of Cancer Research, United Kingdom
European Organisation for Research and Treatment of Cancer - EORTC
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP