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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted16 to 69OtherEORTC-62931
CAN-NCIC-SR3, SR3, NCT00002641

Trial Description


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.

Further Study Information


  • 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.

Eligibility Criteria


  • 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



  • 16 to 69

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC greater than 4,000/mm^3
  • Platelet count greater than 120,000/mm^3
  • No bleeding disorders


  • Bilirubin no greater than 1.25 times normal
  • No severe hepatic dysfunction


  • Creatinine less than 1.6 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No clear history of angina
  • No documented myocardial infarction
  • No existing cardiac failure


  • No serious infection
  • No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer


Biologic therapy:

  • Not specified


  • No prior systemic chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to affected area


  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

  • NCIC-Clinical Trials Group
Penella J. Woll, Study Chair
Vivien H.C. Bramwell, Study Chair

Link to the current record.
NLM Identifier NCT00002641 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to