UnknownPhase 2

Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma

Netherlands118 participantsStarted 2006-10

Plain-language summary

RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This randomized phase II trial is studying the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma.

Who can participate

Age range

18 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 or cytologically confirmed high- or intermediate-grade malignant soft tissue sarcoma\* of 1 of the following cellular types: * Adipocytic (e.g., liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, not otherwise specified) * Fibroblastic (e.g., adult fibrosarcoma, myxofibrosarcoma, or sclerosing epithelioid fibrosarcoma) * So-called fibrohistiocytic (e.g., pleomorphic malignant fibrous histiocytoma \[MFH\], giant cell MFH, or inflammatory MFH) * Leiomyosarcoma * Malignant glomus tumors * Skeletal muscle (e.g., rhabdomyosarcoma, alveolar, or pleomorphic) * Vascular (e.g., epithelioid hemangioendothelioma or angiosarcoma) * Uncertain differentiation (e.g., synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor \[PEComa\], or intimal sarcoma) * Malignant peripheral nerve sheath tumors * Malignant solitary fibrous tumors * Undifferentiated soft tissue sarcomas not otherwise specified * Other types of sarcoma if approved by the study coordinator NOTE: \*Includes malignant tumors of non-organ origin and skin and uterine leiomyosarcoma * The following tumor types are excluded: * Embryonal rhabdomyosarcoma * Chondrosarcoma * Osteosarcoma * Ewing tumors/primitive neuroectodermal tumor (PNET) * Gastrointestinal stromal tumors * Dermatofibrosarcoma protuberans * Inflammator…

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

Six-month progression-free survival, in terms of complete response, partial response, or no change

Trial details

NCT IDNCT00410462

SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2008-09

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