Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma (NCT00002641) | Clinical Trial Compass
CompletedPhase 3
Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Austria, Belgium350 participantsStarted 1995-02
Plain-language 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.
Who can participate
Age range16 Years – 69 Years
SexALL
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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 grea…
Trial details
NCT IDNCT00002641
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC