Trabectedin Maintenance

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Trabectedin Maintenance post 1st-line in STS

Agents: Trabectedin
Phase III
Status  Open, recruiting
Sponsor EORTC in collaboration with PharmaMar

 Further information: https://clinicaltrials.gov/ct/show/NCT02929394 or http://www.eortc.org/research_field/clinical-detail/1447/

 

Maintenance therapy with Trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma

WHO is the trial for?
  • Adult patients (18 years or older) with high grade soft tissue sarcoma that is locally advanced or with metastasis (excluded are subtypes that do not respond to chemotherapy)
  • Patients with a stable disease or who are in remission after 6 cycles of first-line chemotherapy with doxorubicin. Treatment with doxorubicin should only have stopped no more than 6 weeks ago
  • Tumor tissue should be available for histological central review
  • Adequate bone marrow, liver and renal function and coagulation parameters
  • Overall health status of the patient has to be good (WHO performance status ≤ 1)

WHAT is the key question that this trial is attempting to answer?

This trial tries to answer the question if treatment with trabectedin is superior to observation (current standard procedure) in patients with advanced, inoperable and/or metastatic soft tissue sarcoma after they’ve achieved a response or stabilization during first line treatment with doxorubicin. The time till disease progression will be assessed, but also safety and tolerability, and the impact on overall survival.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy and will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

 The study is open (recruiting)

WHERE is the trial available?

The trial is available in several study centers in the France, Germany, The Netherlands, Poland and Spain. For further information please check here: http://www.eortc.org/research_field/clinical-detail/1447/ or https://clinicaltrials.gov/ct/show/NCT02929394

Study contact:

  • Ward Sents, EORTC:
    Phone: +32 2 7741533
    E-Mail: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.

STUDY DESIGN: What does the study look like?

 There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups.
Patients in one group will be assigned to trabectedin (Yondelis®), patients in the other group will be observed.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients. If there are no such organisation in your country, please email us for more information: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.

CONNECT with other patients on this trial

 If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.

SHARE your experience

 You want to share your experience on this trial?
Send us an e-mail to: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

 No results are available at this time. Future results will be linked here.


Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

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