Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced … (NCT01189253) | Clinical Trial Compass
TerminatedPhase 2/3
Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
Stopped: Results of step1: none of the experimental arms fulfills expectations and the study will not continue as a phase III.
United States, Austria, Belgium133 participantsStarted 2011-05
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma.
PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced 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 confirmed intermediate- or high-grade malignant soft tissue sarcoma
* Advanced and/or metastatic disease
* Previously untreated disease
* The following tumor types are not allowed:
* Well-differentiated liposarcoma
* Embryonal rhabdomyosarcoma
* Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
* Osteosarcoma (excluding extraskeletal osteosarcoma)
* Ewing tumors/primitive neuroectodermal tumor (PNET)
* Gastrointestinal stromal tumors (GIST)
* Dermatofibrosarcoma protuberans
* Must have confirmed disease progression based on investigator's judgment prior to study enrollment
* Measurable disease according to RECIST v 1.1 criteria
* Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion
* Formalin fixed paraffin embedded tumor blocks or representative hematoxylin/eosin slides (preferably both) available (local histopathological diagnosis will be accepted for trial entry)
* No prior anticancer therapy for this disease
* No prior anthracycline
* Non-anthracycline therapy for nonmetastatic disease is acceptable
* No known history of CNS metastases or leptomeningeal tumor spread
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100 x 10\^9/L
* Bilirubin norm…
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
Progression-free survival as assessed by RECIST v 1.1 criteria (phase IIB and phase III)
2
Safety (phase IIB)
Trial details
NCT IDNCT01189253
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC