Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT03342300
Eligibility Criteria:
Inclusion Criteria:
* 16 years or older;
* diagnosis of an advanced unresectable or metastatic soft tissue sarcoma, of intermediate or high grade, for which no standard curative therapy is available;
* cumulative dose of anthracycline antibiotic ≥ 300mg/m2;
* stable or responsive to doxorubicin, potential beneficiary;
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, a life expectancy of at least 3 months;
* measurable disease according to RECIST 1.1;
* adequate end-organ and haemopoietic function.
Exclusion Criteria:
* progress over doxorubicin;
* previous mediastinal or cardiac radiotherapy;
* a low-grade tumour according to standard grading systems (eg, American Joint Committee on Cancer grade 1 and 2 or Fédération Nationale des Centres de Lutte Contre le Cancer grade 1);
* significant cardiac dysfunction;
* severe chronic obstructive pulmonary disease;
* a known infection with HIV or active infection with hepatitis B or hepatitis C;
* known brain metastases unless previously treated and well controlled for a period of 3 months or longer;
* combination with other anti-tumor therapy;
* pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT03342300
Study Brief:
Protocol Section:
NCT03342300