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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002641
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 8, 2014
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Kidney Cancer Ovarian Cancer Pheochromocytoma Sarcoma Biological: filgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: isolated perfusion Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA
Study Start Date : February 1995
Actual Primary Completion Date : February 2006
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   16 Years to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002641


Locations
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Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
Investigators
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Study Chair: 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
More Information
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Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002641    
Other Study ID Numbers: EORTC-62931
EORTC-62931
CAN-NCIC-SR3
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: July 2002
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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
Additional relevant MeSH terms:
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Sarcoma
Endometrial Neoplasms
Kidney Neoplasms
Pheochromocytoma
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Uterine Neoplasms
Uterine Diseases
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Doxorubicin
Liposomal doxorubicin
Ifosfamide
Antibiotics, Antineoplastic