Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory,… (NCT00410462) | Clinical Trial Compass
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 range18 Years
SexALL
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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…
What they're measuring
1
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