CompletedPhase 3

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

Austria, Belgium, Canada350 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 range

16 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00002641

SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2006-02

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