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NCT00002641 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-08-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
69 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    filgrastim
    type
    BIOLOGICAL
  2. name
    doxorubicin hydrochloride
    type
    DRUG
  3. name
    ifosfamide
    type
    DRUG
  4. name
    isolated perfusion
    type
    DRUG
  5. name
    adjuvant therapy
    type
    PROCEDURE
  6. name
    conventional surgery
    type
    PROCEDURE
  7. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
350
type
ESTIMATED
Registered outcome plans (not posted results)
Full study description
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.
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.
Source references
references
  1. citation
    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.
    type
    BACKGROUND
  2. citation
    Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group and the NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. doi: 10.1016/S1470-2045(12)70346-7. Epub 2012 Sep 4.
    pmid
    22954508
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      1. context exact
        tion from 41% to 30%), and 5% for doxorubicin without ifosfamide.</li></ul></div></li><li>An additional multicenter randomized trial (<a href="/clinicaltrials/NCT00002641">EORTC-62931</a> [NCT00002641]) that used adjuvant doxorubicin (75 mg/m<span class="sup">2</span>) plus ifosfamide (5,000 mg/m<span class="sup">2</span>) was n
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      2. context exact
        for doxorubicin without ifosfamide.</li></ul></div></li><li>An additional multicenter randomized trial (<a href="/clinicaltrials/NCT00002641">EORTC-62931</a> [NCT00002641]) that used adjuvant doxorubicin (75 mg/m<span class="sup">2</span>) plus ifosfamide (5,000 mg/m<span class="sup">2</span>) was not included in the previous me
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        exact text
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        start
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      3. context exact
        After local therapy, 351 patients were randomly assigned to five 21-day cycles of adjuvant therapy versus observation. The results of <a href="/clinicaltrials/NCT00002641">EORTC-62931</a> differed from those reported in the previous meta-analysis.[<a href="#cit/section_4.47">47</a>] <div class="pdq-content-list"><ul id="_2261">
        end
        105505
        exact text
        NCT00002641
        start
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      4. context exact
        </ul></div></li><li>In a subsequent analysis of pooled individual patient data, the EORTC investigators combined data from this trial (<a href="/clinicaltrials/NCT00002641">EORTC-62931</a>) with data from their previous trial (<a href="http://www.eortc.org/research_field/clinical-detail/62771/" title="http://www.eortc.org/researc
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      source title
      Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 21, 2025
        datetime
        2025-02-21T12:00:00Z
        display
        February 21, 2025

    Preserved source evidence · Not medical advice