An Observational, Multicenter, Open-label Study of the Management of Patients With Advanced Soft Tissue Sarcoma After Failure of Anthracyclines and/or Ifosfamide or Patients Unsuited to Receive These Drugs
- This phase IV study is designed to evaluate, in a real-world setting, usage patterns
and associated outcomes associated with the anticancer treatment and/or best supportive
care in the clinical practice. The primary study analysis will be to collect clinical
data on symptomatic and best response, including tumor control rate, survival, TTP and
PFS. Other endpoints of the study will include an evaluation of on-study subsequent
anticancer treatments, QoL evaluation by using the EORTC QoL test (QLQ-C30) and an
economic cost-effectiveness analysis by using the EQ-5D test.
- The study population will consist of patients with advanced soft tissue sarcoma after
failure of anthracyclines and/or ifosfamide or patients unsuited to receive these
drugs. To be enrolled in this study, the patients must meet all inclusion criteria and
none of the exclusion criteria. Estimated 100 patients will be enrolled.
- Inclusion Criteria
1. Patients of both sexes with histologically diagnosed advanced soft tissue sarcoma
after failure of anthracyclines and/or ifosfamide or patients unsuited to receive
2. Patients must have signed an informed consent document indicating that they
understand the purpose and procedures required for the study, and that they are
willing to participate in the study.
3. Age ≥ 18 years. Exclusion Criteria Withdrawal of the informed consent at any point
of the study will exclude the patient from the study.
- Assigned Intervention
1. Trabectedin treatment The administration of chemotherapy regimen with trabectedin
will be determined by the Investigator's discretion depending on the patients´
conditions and previous chemotherapy.
2. Other conventional care regimens: other palliative chemotherapy or biological
therapy or best supportive care. Patients on the other conventional care regimens
could receive the following preselected treatments options:
A.Palliative chemotherapy or biological therapy (such as Ifosfamide or other anticancer
agents with antitumor effect) as a palliative systemic therapeutic modality that may be
offered to the patient with advanced soft tissue sarcoma.
B.Best supportive care, as a palliative therapeutic modality that may be offered to the
patient with soft tissue sarcoma excluding chemotherapy/biological therapy but including
radiotherapy and non-anticancer medication. Hence, this includes nutritional support,
analgesics, antibiotics, antiemetic, transfusions, appetitive stimulants, antidepressants or
any other symptomatic therapy, palliative surgery and/or psychological support and/or deep
relaxation therapy. Localized radiotherapy to alleviate symptoms (i.e., pain) will be
allowed, provided that the total delivered dose is within a palliative range. All therapies
with potential systemic antitumor effect were excluded as BSC definition
- Subsequent Anticancer Treatments Administered After chemotherapy discontinuation,
patients with documented progressive disease (PD) may be treated with subsequent
anticancer therapies or best supportive care at the Investigators´ discretion. All
subsequent treatments, surgical procedures or radiotherapy will be reported in the CRF.
- The study period starts at study inclusion and will continue until treatment
discontinuation, death or until the predefined date of April 2014, when a final
analysis have to delivered to the Dutch authorities.
- Efficacy Evaluations: Symptomatic response and best response as per the Investigator,
according to RECIST will be assessed. Tumor control rate (CR + PR + SD), TTP, PFS and
OS will be also evaluated.
Time Perspective: Prospective
A J Gelderblom, Prof
Leiden University Medical Center
Netherlands: ZonMw, Netherlands Organisation for Health Research and Development