RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.
Who can participate
Age range
18 Years – 60 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 confirmed soft tissue sarcoma
* Locally advanced unresectable\* OR metastatic disease
* High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: \*Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed
* The following tumor types are eligible:
* Malignant fibrous histiocytoma
* Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma
* Pleomorphic rhabdomyosarcoma
* Synovial sarcoma
* Myxofibrosarcoma, intermediate and high-grade
* Fibrosarcoma
* Leiomyosarcoma
* Angiosarcoma
* Malignant peripheral nerve sheath tumor
* Epithelioid sarcoma
* Alveolar rhabdomyosarcoma
* Unclassifiable sarcoma, not otherwise specified
* The following tumor types are not eligible:
* Gastrointestinal stromal tumor
* Mixed mesodermal tumor
* Chondrosarcoma
* Malignant mesothelioma
* Neuroblastoma
* Osteosarcoma
* Ewing's sarcoma/primitive neuroectodermal tumor
* Desmoplastic small round cell tumor
* Embryonal rhabdomyosarcoma
* Alveolar soft part sarcoma
* Must have a measurable lesion with clinical evidence of progression within the past 6 weeks
* Osseous lesions and pleural effusions are not considered measurable
* No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute ne…
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.
What they're measuring
1
Overall survival
Trial details
NCT IDNCT00061984
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC